As a Field Service Engineer at ASM, you’ll have the opportunities to get involved in a wider scope of work compared to our larger competitors. While the workload is challenging, you are given the independence and autonomy to perform at your peak. This work requires thinking “outside of the box” in an innovative manner, so you must have the ability to collaborate with others to deliver creative solutions, work well under pressure and pay great attention to small details.

If you are chosen for this position, your work location will be in Tongluo, Miaoli, while the office will be located in Taichung, the commuting between locations will be required.

Note: The working location is based in Taichung, and travel to Tongluo for customer support will be required.

Shift work/On call working mode will be required.
Valid driver's license is required for this role.
Domestic and International travel of at least 25%~50% will be required for this role.
The actual job grade will be determined based on skill set and experience.

Responsibilities:

• Evaluate, understand and identify current customer needs, while also anticipating future needs and building long-term sustainable relationship and solutions.
• The ability to develop action plans for problem resolution and present to internal and external customers.
• Ensure communication channels, via phone, email, and presentation, etc. are able to facilitate efficient and consistent customer follow-up.
• Develop improvements for processes, hardware and software for continuous improvement of ASM equipment / business operations. Coach / mentor lower level FSE’s to higher level skill sets.
• Projects manage new evaluations and present to client, you will be responsible for ensuring the success of the project.
• Leading new site start-up and planning/risk assessment for readiness/execution successfully to get customer recognition and satisfaction.
• Define project scope and resource planning together with BU, escalate to Manager for resource gap.
• Capable of working completely independent of supervision on highly complex problems while meeting project/task timelines, objectives and goals.
• Support CS EE /Sales/BU as one team to success site base operation/service.

Qualifications:

• Ability to work in a team environment with tight deadlines and multiple priorities.
• Bachelor Degree or above in an Engineering discipline.
• 3 years or above of technical experience and deep business perspective preferably in the Semiconductor / Capital Equipment / CVD related industry.
• Basic troubleshooting techniques in repairing complex microprocessor controlled electromechanical systems
• Strong positive attitude with excellent customer service skills
• Clear and concise both English/Mandarin verbal and written communications
• Knowledge of structured problem solving techniques
• Ability to work in a team environment, independently and/or with limited supervision
• Ability to handle multiple tasks

About Appier 

Appier is a software-as-a-service (SaaS) company that uses artificial intelligence (AI) to power business decision-making. Founded in 2012 with a vision of democratizing AI, Appier’s mission is turning AI into ROI by making software intelligent. Appier now has 17 offices across APAC, Europe and U.S., and is listed on the Tokyo Stock Exchange (Ticker number: 4180). Visit www.appier.com for more information.

About the role

We're looking for an experienced data engineer to build and scale our data infrastructure. You'll work on mission-critical systems that power our data-driven decision making, designing robust pipelines and optimizing distributed platforms that process massive datasets.

Responsibilities

• Design, develop, and maintain production data pipelines processing hundreds of terabytes of data daily across distributed systems
• Build, manage, and optimize large-scale data platforms including Spark clusters, Kafka clusters, and related big data infrastructure
• Develop and operate data warehouse systems and ETL pipelines for data collection, processing, storage, and analytics
• Profile and tune performance of critical components to optimize throughput, reduce latency, and improve resource efficiency
• Establish architectural foundations and engineering best practices for the platform
• Design frameworks and tooling to streamline software development, deployment, monitoring, and observability
• Provide technical expertise and guidance on big data system design, performance optimization, and scalability challenges

About you

[Minimum qualifications]

• BS/MS degree in Computer Science or related technical field
• 2+ years of hands-on experience building and operating large-scale distributed systems
• Proficiency in Java and/or Scala for production-level development
• Proven experience building ETL pipelines and data processing workflows using Apache Spark
• Experience managing and optimizing data lakes or data warehouses at scale
• Ability to work independently and adapt quickly in fast-paced, dynamic environments
• Self-motivated learner who takes ownership, manages multiple priorities effectively, and thrives in collaborative team settings
• Experience deploying and managing infrastructure on public cloud platforms (AWS, GCP, or Azure)

[Preferred qualifications]

• Proficiency in Python and/or Golang for building production systems
• Experience profiling and optimizing JVM performance for high-throughput applications
• Hands-on experience managing and operating data platforms such as Hadoop, Kafka, Flink, Hive, Trino, Presto, or ClickHouse
• Knowledge of modern open table formats including Apache Iceberg, Delta Lake, or Hudi 
• Active contributions to open source projects (please include your GitHub profile if applicable)

#LI-AK1

What this job can offer you

The Payroll Specialist Lead - China payroll is a critical role within Remote’s dynamic global payroll organization. Nestled within our EOR and Payroll Operations Team, this role is responsible for delivering accurate, compliant payroll operations within assigned countries while also contributing to the improvement and scalability of our global payroll processes.

You will work closely with internal stakeholders across Payroll Operations, Tax, Finance, Product and Customer Success, while coordinating with diverse payroll partners where applicable.

This role is well suited for a mid-to-senior career payroll ops professional who has deep hands-on experience running payroll in complex environments and is comfortable operating in globally distributed teams.

What you bring

• Brings meaningful mid-senior career experience in Pakistani payroll operations, including hands-on responsibility for end-to-end payroll processing in Pakistan
• Has managed payroll in multi-country environments or global organizations, with exposure to different payroll systems and local regulatory frameworks.
• Demonstrates strong understanding of payroll controls, reconciliations, statutory reporting, and compliance requirements.
• Comfortable working with internal and external stakeholders in Remote’s payroll ecosystem, and coordinating cross-functional stakeholders.
• Analytical and detail-oriented, with strong problem-solving skills and the ability to manage complex payroll scenarios.
• Strong written and oral communicator, comfortable working in asynchronous and globally distributed environments.
• Takes ownership of outcomes, raises risks early, and approaches operational challenges with curiosity and accountability.
• Comfortable working in scrappy, quick-moving start-up environments.
• Proficient in payroll tools and data analysis using in-house and external platforms
• Experience working in remote or globally distributed teams is an advantage.
• Demonstrates strong fluency in English; additional languages are a plus.

Key Responsibilities 

• Ensure payroll is processed accurately, on time, and in compliance with country-specific regulations and statutory requirements.
• Own end-to-end payroll execution for assigned jurisdictions, including validation of payroll inputs, payroll calculations, and post-payroll processes.
• Act as a subject matter expert on country payroll requirements, staying up to date with legislative, tax, and regulatory developments that may impact payroll operations.
• Support the operational implementation and rollout of payroll services in new or expanding jurisdictions, ensuring payroll execution processes are effectively integrated into operational workflows.
• Serve as a key point of coordination for internal teams and external stakeholders on country payroll matters.
• Identify and resolve payroll discrepancies, operational risks, or compliance issues, exercising sound judgment when escalating complex matters.
• Contribute to the continuous improvement of payroll operational processes, identifying opportunities to streamline workflows and improve operational transparency.
• Support the development and maintenance of payroll documentation and operational knowledge to ensure processes remain clear, scalable, and aligned with internal governance requirements.
• Partner with cross-functional teams to support system enhancements, statutory updates, and operational improvements impacting payroll.
• Contribute to the adoption of automation and AI-enabled tools that improve payroll operational efficiency, accuracy, and scalability.
• Participate in testing activities related to payroll system developments, enhancements, and process improvements to ensure operational readiness.

Practicals

• You'll report to: Manager, Payroll Operations
• Team: Global Payroll Operations
• Location: APAC
• Start date: As soon as possible

Application process

1. Interview with recruiter
2. Interview with team members (no managers present)
3. Interview with future manager
4. Bar Raiser Interview
5. Prior employment verification check 

Job’s Mission

As a Demand Planner, you will play a critical role in ensuring service readiness by proactively planning, kitting, and scheduling spares to support sanitation and preventive maintenance activities. This role sits at the center of Field Service, Service Operations, and Supply Chain, helping minimize equipment downtime through accurate forecasting, strong material control, and effective cross‑functional coordination. You will operate in a fast‑paced, data‑driven environment where ownership, precision, and responsiveness are key to success.

What You Will Be Working On

• Kit Preparation & Management
  • Build and manage clean kits to ensure Field Service Engineers and customers have all required materials prior to job execution.
• Kit Planning & Scheduling
  • Develop and maintain kitting schedules aligned with preventive maintenance (PM) cycles and service demand.
• Inventory & Supplier Management
  • Analyze historical demand and validate forecasts to optimize planning accuracy.
  • Manage inventory levels, including excess & obsolete (E&O) materials and inventory rebalancing.
  • Support NPI planning, initial stocking strategies, and part lifecycle transitions.
  • Monitor MRP accuracy, resolve data integrity issues, and respond to MRP validation inquiries from purchasing teams.
  • Proactively expedite materials when potential shortages are identified.
• Cross‑Functional Coordination
  • Act as the primary liaison among Field Service Engineers, Customer Service Representatives, Buyers, Forecasters, and Logistics to ensure smooth execution and timely material availability.

What We Are Looking For

• Bachelor’s degree in Supply Chain, Engineering, Business, or a related field
• 3–6 years of experience in customer service, order fulfillment, material planning, or supply chain
• Knowledge of forecasting, planning, and scheduling systems, inventory management principles, and spares logistics
• Experience working with SAP and Microsoft Office (Excel, Word, PowerPoint)
• Strong planning and organizational skills, with the ability to manage multiple priorities in a deadline‑driven environment
• Excellent communication skills, including strong English proficiency (written and spoken) to support global collaboration

What Sets You Apart

• Experience in the semiconductor, electronics, or high‑volume manufacturing industry
• Hands‑on experience supporting NPI and complex part lifecycle management
• Strong data discipline with a high level of attention to detail and data integrity
• Proven ability to work independently while taking full ownership of deliverables
• Proactive mindset with the ability to anticipate issues and drive solutions across teams

Job's mission

As a Demand Planner, you will play a critical role in ensuring service readiness by proactively planning, kitting, and scheduling spares to support sanitation and preventive maintenance activities. This role sits at the center of Field Service, Service Operations, and Supply Chain, helping minimize equipment downtime through accurate forecasting, strong material control, and effective cross‑functional coordination.

What you will be working on

• Kit Preparation & Management
  • Build and manage clean kits to ensure Field Service Engineers and customers have all required materials prior to job execution.
• Kit Planning & Scheduling
  • Develop and maintain kitting schedules aligned with preventive maintenance (PM) cycles and service demand.
• Inventory & Supplier Management
  • Analyze historical demand and validate forecasts to optimize planning accuracy.
  • Manage inventory levels, including excess & obsolete (E&O) materials and inventory rebalancing.
  • Support NPI planning, initial stocking strategies, and part lifecycle transitions.
  • Monitor MRP accuracy, resolve data integrity issues, and respond to MRP validation inquiries from purchasing teams.
  • Proactively expedite materials when potential shortages are identified.
• Cross‑Functional Coordination
  • Act as the primary liaison among Field Service Engineers, Customer Service Representatives, Buyers, Forecasters, and Logistics to ensure smooth execution and timely material availability.

What we are looking for

• Bachelor’s degree in Supply Chain, Engineering, Business, or a related field
• 3–6 years of experience in customer service, order fulfillment, material planning, or supply chain
• Knowledge of forecasting, planning, and scheduling systems, inventory management principles, and spares logistics
• Experience working with SAP and Microsoft Office (Excel, Word, PowerPoint)
• Strong planning and organizational skills, with the ability to manage multiple priorities in a deadline‑driven environment
• Excellent communication skills, including strong Japanese & English proficiency (written and spoken) to support global collaboration

What sets you apart

• Experience supporting Japanese customers or market
• JLPT N1 or N2 certification in Japanese
• Experience in the semiconductor, electronics, or high‑volume manufacturing industry
• Hands‑on experience supporting NPI and complex part lifecycle management
• Strong data discipline with a high level of attention to detail and data integrity
• Proven ability to work independently while taking full ownership of deliverables
• Proactive mindset with the ability to anticipate issues and drive solutions across teams

What you will be working on

• Kits & Repair Management  
  • Create tracking reports to monitor the status of customer parts, repairs, RMAs, and service requests processing.  
  • Develop and maintain kits schedules aligned with preventive maintenance (PM) cycles and service demand. 
  • Ensure accurate PM (preventive maintenance) activity reporting and data sharing with internal teams, external vendors, and customers. 

• Order fulfilment 
  • Create and maintain accurate Sales Orders and Reports within SAP. 
  • Deal with stock operations and identify/reconcile discrepancies between physical and system inventory records. 

• Cross‑Functional Coordination 
  • Collaborate with business development and account teams to align on customer service level agreements for spares and execute processes accordingly. 
  • Act as the primary liaison among Field Service Engineers, Planners, Buyers, Forecasters, and Logistics to ensure smooth execution. 
  • Independently facilitate cross-regional meetings to ensure alignment on global operation goals. 

• Customer Relationship 
  • Proactively escalate and follow up on customer requests via phone & email to ensure timely resolution.  
  • Cultivate a deep understanding of customer requirements and build strong customer relationships. 

What we are looking for

• Bachelor’s degree in Supply Chain, Business, or a related field 
• 6–8 years of experience in customer service, order fulfillment, material planning, or supply chain 
• Experience in managing Spares, Customer Fulfillment, and Logistics operations is preferred  
• Structured and collaborative problem-solving skills leveraging analytics
• Experience in working with SAP and Microsoft Office (Excel, Word, PowerPoint) 
• Excellent communication skills, including professional English proficiency (written and spoken) to support global collaboration 

What sets you apart

• Proactive Ownership: You don't just wait for instructions; you identify gaps and take the lead in closing them. 
• Analytical Edge: You have a "knack" for numbers and can tell a story through data to influence decision-making. 
• Global Mindset: You are comfortable working across time zones and enjoy the challenge of coordinating with diverse teams. 
• Adaptability: You thrive in fast-paced environments and can pivot quickly when customer priorities shift. 

About Appier 

Appier (TSE: 4180) is an AI-native Agentic AI as a Service (AaaS) company that empowers businesses to create value through cutting-edge AdTech and MarTech solutions. Founded in 2012 with the vision of “Making AI Easy by Making Software Intelligent,” Appier helps businesses turn AI into ROI through its Ad Cloud, Personalization Cloud, and Data Cloud—each powered by Agentic AI that enables autonomous, adaptive, and real-time decision-making. Today, Appier operates 17 offices across APAC, the US, and EMEA, and is listed on the Tokyo Stock Exchange. Learn more at www.appier.com.

About the role

We are looking for a Machine Learning Scientist Intern to join the Enterprise Solution Science Team.
This team focuses on applying cutting-edge ML technologies to real-world marketing problems by combining them with omnichannel customer data.

We are currently looking for individuals who can commit to an internship schedule of 2~4 days (16~32 hours) per week. This internship opportunity entails a minimum duration of 6 months, beginning from the present date. We advise prospective applicants to carefully assess their availability for this commitment before submitting their applications.

[ Due to the hybrid work model, this position cannot be fully remote and requires working in the Taiwan office. ]

Responsibilities

• Work on one of the following ML or LLM topics: user prediction, recommendation, agents, and chatbots.
• Collaborate closely with senior ML scientists to define ML problems, algorithm development, conduct evaluations, monitoring, and continuous optimization.
• Stay up to date with the latest research and proactively propose innovative applications.

About you

[Minimum qualifications]

• Bachelor's degree in Computer Science, Machine Learning, Mathematics, Electrical Engineering, or related fields. (Master's degree preferred)
• 2+ years of experience in ML or LLM.
• Proficient in Python.
• Proficient in one of the below
  1.Core ML and deep learning concepts: feature engineering, recommendation, regression, classification, clustering, etc.
  2.LLM applications development techniques: RAG, agent, chatbots.
• Able to evaluate models with systematic and quantitative analysis.
• Strong data intuition and familiarity with basic statistical concepts.

[Preferred qualifications]

• Impact-driven mindset, strong analytical and problem-solving skills, and a continuous passion for learning cutting-edge technologies.
• Proficient in using LLM-powered tools (e.g., Github Copilot, ChatGPT) to boost development productivity.

#LI-AK1

As a Field Service Engineer at ASM, you’ll have the opportunities to get involved in a wider scope of work compared to our larger competitors. While the workload is challenging, you are given the independence and autonomy to perform at your peak. This work requires thinking “outside of the box” in an innovative manner, so you must have the ability to collaborate with others to deliver creative solutions, work well under pressure and pay great attention to small details.

Shift work/On call working mode will be required.
Valid driver's license is required for this role.
Domestic and International travel of at least 25%~50% will be required for this role. 
The actual job grade will be determined based on skill set and experience.

Responsibilities:

• Evaluate, understand and identify current customer needs, while also anticipating future needs and building long-term sustainable relationship and solutions.
• The ability to develop action plans for problem resolution and present to internal and external customers.
• Ensure communication channels, via phone, email, and presentation, etc. are able to facilitate efficient and consistent customer follow-up.
• Develop improvements for processes, hardware and software for continuous improvement of ASM equipment / business operations. Coach / mentor lower level FSE’s to higher level skill sets.
• Projects manage new evaluations and present to client, you will be responsible for ensuring the success of the project.
• Leading new site start-up and planning/risk assessment for readiness/execution successfully to get customer recognition and satisfaction.
• Define project scope and resource planning together with BU, escalate to Manager for resource gap.
• Capable of working completely independent of supervision on highly complex problems while meeting project/task timelines, objectives and goals.
• Support CS EE /Sales/BU as one team to success site base operation/service.

Qualifications:

• Ability to work in a team environment with tight deadlines and multiple priorities.
• Bachelor Degree or above in an Engineering discipline.
• 0-3 or 4~8 years above of technical experience and deep business perspective preferably in the Semiconductor / Capital Equipment / CVD related industry. (EPI, CVD or PECVD relevant experience is a plus).
• Basic troubleshooting techniques in repairing complex microprocessor controlled electromechanical systems
• Strong positive attitude with excellent customer service skills
• Clear and concise both English/Mandarin verbal and written communications
• Knowledge of structured problem solving techniques
• Ability to work in a team environment, independently and/or with limited supervision
• Ability to handle multiple tasks

Astera Labs is a global leader in purpose-built connectivity solutions that unlock the full potential of AI and cloud infrastructure. Our Intelligent Connectivity Platform integrates PCIe®, CXL®, and Ethernet semiconductor-based solutions and the COSMOS software suite of system management and optimization tools to deliver a software-defined architecture that is both scalable and customizable. Inspired by trusted relationships with hyperscalers and the data center ecosystem, we are an innovation leader delivering products that are flexible and interoperable. Discover how we are transforming modern data-driven applications at www.asteralabs.com.

Job Summary

We are seeking a student intern to drive product quality improvements across both Astera Lab’s semiconductor and board-level products. In this role, the candidate will perform failure analysis for customer returns. The candidate will also compile 8D reports to communicate the analysis findings to the customers.

Key Responsibilities

· Perform system-level test for the customer returns on a bench in the lab.

· Review ATE test log files.

· Work with third-party labs to perform electrical FA (EFA) for more in-depth analysis.

· Log analysis results to the portal system daily.

· Work with internal teams and suppliers to drive product quality improvements.

· Write up analysis reports to provide updates to the customers. Participate in the meetings with customers to present the technical findings.

· Bring up and validate new test equipment in the lab. Update the lab inventory list.

· Perform additional tasks assigned by the Director of Field Quality Engineering.

Education & Experience

· Final year students from Bachelor’s degree are welcome to apply.

· Students from Master’s degree are preferred.

Technical Skills

· Good knowledge of IC fabrication, packaging, board assembly (SMT), and test processes

· Strong communication skills in English and Mandarin.

Working Conditions:

· May require occasional travel to customer sites within Taiwan.

· Must be flexible to work on-site and available during business hours for at least 3 days per week.

We know that creativity and innovation happen more often when teams include diverse ideas, backgrounds, and experiences, and we actively encourage everyone with relevant experience to apply, including people of color, LGBTQ+ and non-binary people, veterans, parents, and individuals with disabilities.

【About the role】

We are seeking a Data Analyst Intern in Taiwan that will be part of a product R&D team. The role will perform data analysis to help Appier teams to answer business or operational questions.

We are seeking potential candidates who can commit to 2-3 days a week and participate in the internship for a minimum of 6 months, starting immediately. Please ensure that you have checked your availability before applying.

【Responsibilities】

• Interpret trends or patterns from complex data sets by using statistical and visualization tools.
• Conduct data analysis reports to illustrate the results and insight
• Working with scientists and engineers to monitor and diagnose the system
• Develop tools and systems that optimize analysis process efficiency and report quality.

【About you】

[Minimum qualifications]

• Senior students in college or graduate students in related field
• Good analytical skills to extract meaningful insights from the data.
• Good ability to communicate data analysis insight to audiences with different backgrounds.
• Proficient oral and written communication skills in English.
• Analytical skills and tools: Statistics knowledge and skills, using SQL to do basic data extraction and aggregation, Spreadsheet/Excel.
• Machine Learning skills: sufficient know-how of machine learning and basic experience of using machine learning tools.
• Programming skill: can write Python scripts for simple job automation.

 [Preferred qualifications]

• Working experiences in digital advertising industries.
• Hands-on experience in utilizing analytic/visualization tools (SQL, R, Tableau).
• Advanced Python programming: e.g. able to do complex analysis using Python.
• Experience in writing Spark programs for data analysis.

About Appier
Appier (TSE: 4180) is an AI-native Agentic AI as a Service (AaaS) company that empowers businesses to create value through cutting-edge AdTech and MarTech solutions. Founded in 2012 with the vision of “Making AI Easy by Making Software Intelligent,” Appier helps businesses turn AI into ROI through its Ad Cloud, Personalization Cloud, and Data Cloud—each powered by Agentic AI that enables autonomous, adaptive, and real-time decision-making. Today, Appier operates 17 offices across APAC, the US, and EMEA, and is listed on the Tokyo Stock Exchange. Learn more at www.appier.com.

About the role
As a Compliance Policy Intern at Appier, being positioned under Infosec team, you will support the Senior Compliance Program Manager in monitoring global regulatory trends, managing internal documentation, and ensuring business’ adherence to international data and AI regulations, as well as industrial standards. You will play a key role in tracking the evolving landscape of AI governance and data privacy across multiple jurisdictions.

Responsibilities

• Regulatory Research & Tracking: Monitor and provide weekly news briefs on international data laws and AI governance trends across regions including the EU, US, Japan, Korea, Singapore, Hong Kong, Vietnam, and the Philippines.
• Policy Analysis: Research specific legislative developments, such as the EU AI Act, US Executive Orders, and California state bills (e.g., SB 1047, AB 1018), and summarize their implications for the company.
• Managing the data subject request mechanism: Support compliance function by managing contract review tickets and data subject request (DSR) tickets within internal systems, including tracking of incoming mails and response to those requests via internal systems.
• AI & IP Governance:  Research copyright compliance policies related to AI-generated works.
• Security questionnaire: Use AI tools such as NotebookLLM or Claude to fill out security questionnaires from clients and partners

About you

• Legal & Regulatory Interest: A strong interest in international data privacy laws (GDPR, PDPA) and emerging AI regulations (EU AI Act/ Korean Basic AI Act).
• Analytical Skills: Ability to synthesize complex legal updates into concise briefings and comparison tables.
• Bilingual Proficiency: Ability to work with both English and Mandarin legal texts and draft notes in both languages.
• Capacity in Japanese or Korean is a plus
• Capacity to use AI tool such as Clause code also a plus
• Attention to Detail: Experience in managing high volumes of documentation and tracking tickets accurately.
• Research Ability: Proficient in conducting deep-dive research into case law (e.g., Thomson Reuters v. ROSS) and official government guidance.

#LI-RL1

【工作內容】

- 協助企業盡職調查之資料蒐集(會頻繁利用英、日文進行關鍵字搜尋及閱覽文件)

- 協助法務部門日常行政與文書作業（如：合約查詢、文件寄送、歸檔及其他主管交辦事項）

- 每週排班時間16-20個小時（每週到班3-4天）

- 可長期配合工讀者優先考慮 

【徵求條件】

- 對時事、新聞、刑事犯罪、金融、科技、法律等議題具備一定敏感度，願意投入時間探索

- 具日文能力者(JLPT N2或以上)為佳

- 特質：細心耐心、認真負責，且常保好奇心

- 不需具備法律相關科系背景

- 上班時段可彈性協調

Company Introduction  

Coupang is reimagining the shopping experience with the goal of wowing each customer from the instant they open the Coupang app to the moment an order is delivered to their door.  
 
Our services in Taiwan include “Rocket Delivery” which offers next-day delivery for a wide selection of items at affordable prices, “Rocket Oversea” which offers free international delivery on millions of best-selling products from Korea, the U.S., and beyond. 

We are looking for talents to help us lead Coupang’s expansion in Taiwan. This is an exceptional opportunity to become a part of Coupang’s growth in Taiwan and create a world where our customers wonder, “How did I ever live without Coupang?”   

Company Introduction  

Coupang is reimagining the shopping experience with the goal of wowing each customer from the instant they open the Coupang app to the moment an order is delivered to their door.  
 
Our services in Taiwan include “Rocket Delivery” which offers next-day delivery for a wide selection of items at affordable prices, “Rocket Oversea” which offers free international delivery on millions of best-selling products from Korea, the U.S., and beyond. 

We are looking for talents to help us lead Coupang’s expansion in Taiwan. This is an exceptional opportunity to become a part of Coupang’s growth in Taiwan and create a world where our customers wonder, “How did I ever live without Coupang?”   

Role Overview  

The General Affairs Manager ensures smooth operations at HQ and fulfillment sites by managing facilities, procurement, infrastructure, and employee welfare.

What You Will Do 

• Facility Management:Oversee office spaces, facilities, equipment, inventory control, and procurement.
• Employee Welfare:Optimize welfare programs, including benefits, allowances, meals, and shuttle services.
• Operational Efficiency:Enhance working environments and manage administrative duties.
• General Administration:Support events, manage communications, documents, budgets, and administrative costs.
• Safety and Compliance:Ensure safety checks and compliance with laws and regulations.
• Communication:Facilitate communication between HQ and fulfillment centers, ensuring clear policy dissemination and issue resolution.

Basic Qualifications  

• Facility Management:Oversee office spaces, facilities, equipment, inventory control, and procurement.
• Project Management: Responsible for planning, executing, and monitoring general affairs projects.
• Employee Welfare:Optimize welfare programs, including benefits, allowances, meals, and shuttle services.
• Operational Efficiency:Enhance working environments and manage administrative duties.
• General Administration:Support events, manage communications, documents, budgets, and administrative costs.
• Safety and Compliance:Ensure safety checks and compliance with laws and regulations.
• Communication:Facilitate communication between HQ and fulfillment centers, ensuring clear policy dissemination and issue resolution.
• Recruitment Process
• Application Review - Phone Interview - Onsite (or Virtual Onsite) Interview – Offer
• The exact nature of the recruitment process may vary according to the specific job and may be changed due to scheduling or other circumstances.
• Interview schedules and the results will be informed to the applicant via the e-mail address submitted at the application stage. 

Preferred Qualifications 

• This job posting may be closed prior to the stated end date for application if all openings are filled.
• Coupang has the right to rescind an offer of employment if a candidate is found to have submitted false information as part of the application process.
• Coupang does not discriminate against disabled applicants or those with veteran status. We are proud to offer equal opportunities for all applicants. 

Recruitment Process and Others  

Recruitment Process  

• Application Review - Phone Interview - Onsite (or Virtual Onsite) Interview – Offer
• The exact nature of the recruitment process may vary according to the specific job and may be changed due to scheduling or other circumstances.
• Interview schedules and the results will be informed to the applicant via the e-mail address submitted at the application stage. 

Details to Consider 

• This job posting may be closed prior to the stated end date for application if all openings are filled.
• Coupang has the right to rescind an offer of employment if a candidate is found to have submitted false information as part of the application process.
• Those eligible for employment protection (recipients of veteran’s benefits, the disabled, etc.) may receive preferential treatment for employment in accordance with applicable laws. 

Privacy Notice​ 

• Your personal information will be collected and managed by Coupang as stated in the Application Privacy Notice located below: https://www.coupang.jobs/privacy-policy/​ 

Please complete the attached Internal Transfer Request Form and submit.   

Please make sure to apply with your Coupang e-mail address.   

Company Introduction  

Coupang is reimagining the shopping experience with the goal of wowing each customer from the instant they open the Coupang app to the moment an order is delivered to their door.  
 
Our services in Taiwan include “Rocket Delivery” which offers next-day delivery for a wide selection of items at affordable prices, “Rocket Oversea” which offers free international delivery on millions of best-selling products from Korea, the U.S., and beyond. 

We are looking for talents to help us lead Coupang’s expansion in Taiwan. This is an exceptional opportunity to become a part of Coupang’s growth in Taiwan and create a world where our customers wonder, “How did I ever live without Coupang?”   

Role Overview  

The General Affairs Manager ensures smooth operations at HQ and fulfillment sites by managing facilities, procurement, infrastructure, and employee welfare.

What You Will Do 

• Facility Management:Oversee office spaces, facilities, equipment, inventory control, and procurement.
• Employee Welfare:Optimize welfare programs, including benefits, allowances, meals, and shuttle services.
• Operational Efficiency:Enhance working environments and manage administrative duties.
• General Administration:Support events, manage communications, documents, budgets, and administrative costs.
• Safety and Compliance:Ensure safety checks and compliance with laws and regulations.
• Communication:Facilitate communication between HQ and fulfillment centers, ensuring clear policy dissemination and issue resolution.

Basic Qualifications  

• Facility Management:Oversee office spaces, facilities, equipment, inventory control, and procurement.
• Project Management: Responsible for planning, executing, and monitoring general affairs projects.
• Employee Welfare:Optimize welfare programs, including benefits, allowances, meals, and shuttle services.
• Operational Efficiency:Enhance working environments and manage administrative duties.
• General Administration:Support events, manage communications, documents, budgets, and administrative costs.
• Safety and Compliance:Ensure safety checks and compliance with laws and regulations.
• Communication:Facilitate communication between HQ and fulfillment centers, ensuring clear policy dissemination and issue resolution.
• Recruitment Process
• Application Review - Phone Interview - Onsite (or Virtual Onsite) Interview – Offer
• The exact nature of the recruitment process may vary according to the specific job and may be changed due to scheduling or other circumstances.
• Interview schedules and the results will be informed to the applicant via the e-mail address submitted at the application stage. 

Preferred Qualifications 

• This job posting may be closed prior to the stated end date for application if all openings are filled.
• Coupang has the right to rescind an offer of employment if a candidate is found to have submitted false information as part of the application process.
• Coupang does not discriminate against disabled applicants or those with veteran status. We are proud to offer equal opportunities for all applicants. 

Recruitment Process and Others  

Recruitment Process  

• Application Review - Phone Interview - Onsite (or Virtual Onsite) Interview – Offer
• The exact nature of the recruitment process may vary according to the specific job and may be changed due to scheduling or other circumstances.
• Interview schedules and the results will be informed to the applicant via the e-mail address submitted at the application stage. 

Details to Consider 

• This job posting may be closed prior to the stated end date for application if all openings are filled.
• Coupang has the right to rescind an offer of employment if a candidate is found to have submitted false information as part of the application process.
• Those eligible for employment protection (recipients of veteran’s benefits, the disabled, etc.) may receive preferential treatment for employment in accordance with applicable laws. 

Privacy Notice​ 

• Your personal information will be collected and managed by Coupang as stated in the Application Privacy Notice located below: https://www.coupang.jobs/privacy-policy/​ 

As a Field Service Engineer at ASM, you’ll have the opportunities to get involved in a wider scope of work compared to our larger competitors. While the workload is challenging, you are given the independence and autonomy to perform at your peak. This work requires thinking “outside of the box” in an innovative manner, so you must have the ability to collaborate with others to deliver creative solutions, work well under pressure and pay great attention to small details.

Shift work/On call working mode will be required.
Valid driver's license is required for this role.
Domestic and International travel of at least 25%~50% will be required for this role. 
The actual job grade will be determined based on skill set and experience.

Responsibilities:

• Evaluate, understand and identify current customer needs, while also anticipating future needs and building long-term sustainable relationship and solutions.
• The ability to develop action plans for problem resolution and present to internal and external customers.
• Ensure communication channels, via phone, email, and presentation, etc. are able to facilitate efficient and consistent customer follow-up.
• Develop improvements for processes, hardware and software for continuous improvement of ASM equipment / business operations. Coach / mentor lower level FSE’s to higher level skill sets.
• Projects manage new evaluations and present to client; you will be responsible for ensuring the success of the project.
• Leading new site start-up and planning/risk assessment for readiness/execution successfully to get customer recognition and satisfaction.
• Define project scope and resource planning together with BU, escalate to Manager for resource gap.
• Capable of working completely independent of supervision on highly complex problems while meeting project/task timelines, objectives and goals.
• Support CS EE /Sales/BU as one team to success site base operation/service.

Qualifications:

• Ability to work in a team environment with tight deadlines and multiple priorities.
• Bachelor Degree or above in an Engineering discipline.
• 0-3 or 4~8 years above of technical experience and deep business perspective preferably in the Semiconductor / Capital Equipment / CVD related industry. (EPI, CVD or PECVD relevant experience is a plus).
• Basic troubleshooting techniques in repairing complex microprocessor controlled electromechanical systems
• Strong positive attitude with excellent customer service skills
• Clear and concise both English/Mandarin verbal and written communications
• Knowledge of structured problem solving techniques
• Ability to work in a team environment, independently and/or with limited supervision
• Ability to handle multiple tasks

As a Field Service Engineer at ASM, you’ll have the opportunities to get involved in a wider scope of work compared to our larger competitors. While the workload is challenging, you are given the independence and autonomy to perform at your peak. This work requires thinking “outside of the box” in an innovative manner, so you must have the ability to collaborate with others to deliver creative solutions, work well under pressure and pay great attention to small details.

Shift work/On call working mode will be required.
Valid driver's license is required for this role.
Domestic and International travel of at least 25%~50% will be required for this role.
The actual job grade will be determined based on skill set and experience.

Responsibilities:

• Evaluate, understand and identify current customer needs, while also anticipating future needs and building long-term sustainable relationship and solutions.
• The ability to develop action plans for problem resolution and present to internal and external customers.
• Ensure communication channels, via phone, email, and presentation, etc. are able to facilitate efficient and consistent customer follow-up.
• Develop improvements for processes, hardware and software for continuous improvement of ASM equipment / business operations. Coach / mentor lower level FSE’s to higher level skill sets.
• Projects manage new evaluations and present to client, you will be responsible for ensuring the success of the project.
• Leading new site start-up and planning/risk assessment for readiness/execution successfully to get customer recognition and satisfaction.
• Define project scope and resource planning together with BU, escalate to Manager for resource gap.
• Capable of working completely independent of supervision on highly complex problems while meeting project/task timelines, objectives and goals.
• Support CS EE /Sales/BU as one team to success site base operation/service.

Qualifications:

• Ability to work in a team environment with tight deadlines and multiple priorities.
• Bachelor Degree or above in an Engineering discipline.
• 0-3 or 4~8 years above of technical experience and deep business perspective preferably in the Semiconductor / Capital Equipment / CVD related industry. (EPI, CVD or PECVD relevant experience is a plus).
• Basic troubleshooting techniques in repairing complex microprocessor controlled electromechanical systems
• Strong positive attitude with excellent customer service skills
• Clear and concise both English/Mandarin verbal and written communications
• Knowledge of structured problem solving techniques
• Ability to work in a team environment, independently and/or with limited supervision
• Ability to handle multiple tasks

About the Role

You will own the factory execution layer that translates quality problems into implemented fixes at our supplier partners across Taiwan and Southeast Asia. You will build the supplier quality function — yield governance, CAPA discipline, field failure closure — and you will personally drive cross-product factory issues to closure on a defined timeline. The role carries authority to hold shipments and halt production for quality.

What You'll Do

• Cross-Product Factory Execution: Take full ownership of factory-side issues regardless of product line or supplier. Upon receiving a defined problem and proposed fix, drive the implementation through the supplier to verified closure. Translate engineering intent into floor-level action, replacing ambiguity with strict accountability and clear timelines.
• Quality Systems and Data Ingestion: Build yield and failure data infrastructure featuring automated threshold alerts and cross-product failure mode tracking. Lead the Production Data program and define required fields (yields, cycle times, retest rates, test coverage, defect Pareto). Partner with internal team to ingest data into our warehouse, replacing ad-hoc supplier reports with quality dashboards.
• Supplier Production Quality: Establish yield review cadence at each supplier. Drive PCBA yield, functional test yield, burn-in yield, and time-to-failure analysis. Chair weekly quality reviews with supplier leadership and hold production when quality evidence warrants.
• NPI Quality: Partner with HW Engineering on DFM and DFT reviews.
• CAPA and Corrective Action: Own the supplier CAPA program end-to-end. Drive root cause to evidence-backed closure with a focus on preventative action. Maintain a CAPA record that withstands ISO audit and IPO diligence.
• Field Failure Analysis: Close the loop from field returns to supplier corrective action. Partner with HW Engineering and third-party labs on failure analysis. Feed findings into design, process, and incoming inspection changes.
• Supplier Audits: Conduct on-site process audits at suppliers and critical sub-tier suppliers. Validate test equipment calibration, operator training, process adherence, and document control. Report findings in audit-grade format.
• Test Coverage and Test Log Governance: Define testing requirements, coverage levels, and data retention standards for each supplier. Identify and close gaps across stations and product lines.
• Strategic Foundation: Establish the data foundation for supplier scorecards, SBRs, and board-level quality reporting. Establish yield review cadence at all primary suppliers and close the open supplier CAPA backlog to audit-grade standard.

What You Bring 

• Five or more years in factory quality, supplier quality, manufacturing engineering, or factory operations roles at a hardware or electronics company.  
• Demonstrated track record of driving cross-functional manufacturing problems to implemented closure. Direct experience managing supplier or contract manufacturing quality in Taiwan and Southeast Asia.
• BS or MS in Electrical or Mechanical Engineering. Six Sigma Black Belt or equivalent formal training. Working knowledge of ISO 90001:2015, APQP, PPAP, 8D, and SPC.
• Native or fully fluent Mandarin, including reading and writing capability sufficient to review Chinese-language QC reports, work instructions, and supplier responses.  Professional English for US team communication, technical documentation, and executive presentation. 
• Electronics manufacturing depth: PCBA assembly, functional test, burn-in, box build.  Working knowledge of mechanical assembly processes and materials. Experience in imaging, IoT, wireless, access control, or adjacent connected hardware is preferred.
• Advanced data analysis skillset.
• Prioritize verified effectiveness over status updates; You hold suppliers and internal team to firm deadlines and deliverables. Serve as the primary point of contact for Engineering, Sourcing, and Supply Chain Management to resolve factory issues.
• Ability to travel 30% to supplier factory sites (primarily Taiwan, Vietnam, Thailand, with occasional travel to China). Occasional travel to US headquarters.

Bonus

• Master’s degree or MBA.
• Prior experience building a quality function in region.
• ASQ CQE, CQA, or CRE certification.
• Experience with security, surveillance, or access control hardware.
• Prior experience integrating supplier or factory data into a centralized data warehouse or analytics platform.

Taiwan Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Private medical insurance by Nan Shan Life Insurance
• Permanent employees of Verkada Taiwan are eligible for full participation to the group insurance scheme, including accidental death and dismemberment, critical illness, accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Spouses and immediate dependents are eligible to participate in the scheme for accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, generous time off, and personal sick time
• Professional development stipend
• Wellness/fitness benefits
• Meal stipend
• Commuter benefits 

Additional Information 

• You must be independently authorized to work in Taiwan. We are unable to sponsor or take over sponsorship of an employment visa for this role, at this time.

At Flexport, we believe global trade can move the human race forward. That’s why it’s our mission to make global commerce so easy there will be more of it. We’re shaping the future of a $10T industry with solutions powered by innovative technology and exceptional people. Today, companies of all sizes—from emerging brands to Fortune 500s—use Flexport technology to move more than $19B of merchandise across 112 countries a year. 

The recent global supply chain crisis has put Flexport center stage as we continue to play a pivotal role in how goods move around the world. We are proud to have the support of the best investors in the game who believe in our mission, solutions and people. Ready to tackle global challenges that impact business, society, and the environment? Come join us.

The opportunity:

The role of the Ops Associate is a critical part of making Flexport’s mission to make global trade easy for everyone a reality. Flexport today connects almost 10,000 clients and suppliers across 109 countries. In this role, your direct customers are the partners within your region: our account management and customs teams, subcontractors, carriers, terminals and trucking providers. Your work directly supports Flexport’s end customers in achieving their logistics goals. Most importantly, you will play a pivotal role in building the next operational model at Flexport: allowing us to effectively scale to achieve our mission of making global trade easier for everyone.

This role is designed to problem solve impactful operational challenges as part of our Global team while developing specialized expertise in supply chain operations. As the person who executes service delivery for our clients, you have the unique opportunity to help your regional account team spot opportunities to improve and grow our customers’ business. You will be charged with helping Flexport account management teams and clients solve exceptional challenges in order to move their shipments in less time with lower costs and via improved productivity by your team, unblocking issues and establishing procedures to prevent them in the future.

Scope of Duties:

• Execute booking and documentation processes with clients /carriers
• Timely shipment troubleshooting and exception escalation / handling
• Work intimately with Flexport AM, Planning team to ensure an effective end to end export process.
• Coach junior specialists on the daily job. 
• Plan and execute special freight operations (i.e. DG, reefer, etc). 
• Assist Sr. Associate on new business/process implementation, new projects and new tasks. 
• Support internal and external clients to make the best decision with your expertise;
• Live and act with integrity guided by the company values including sustaining a high bar for operational quality and service.
• Inform the business process and software capability needs to help scale our growing team while improving quality, service, efficiency and regulatory compliance.
• Contribute to the development and implementation of the procedure and system to differentiate Flexport operations from the industry.

What you will need: 

Experience:

• BA/BS degree 
• Minimum 3 years of experience in logistics, freight forwarding, supply chain, ocean carrier operations, or consulting (ocean freight knowledge is a plus) 

What you will learn: 

• You will learn what it takes to lead small teams in the execution of day-to-day tactical tasks.
• You will learn how to thrive in an ambiguous environment, research and test operational hypotheses and inform the strategy of a newly built team.

• You will gain specialist expertise to become an ocean or network operations and intermodal subject matter expert within the company. You are the leading advisor in this area, someone our clients, partners, and internal teams go to for advice and strategy.
• You will gain the ability to continuously improve the client experience through a deep industry understanding. You are singularly positioned to realize how we can both work within and push the logistics industry forward to meet the standards of Flexport’s client-centric service.

The opportunity:

As a Sr. Air Freight Manager you are part of the core regional leadership team at Flexport overseeing the regional Air business of Flexport. You are a strategic thinker and a strong change leader able to set and implement the strategic roadmap. You excel at relationship building and can create strong partnerships internally and externally (carriers, customers) to support our strategy. You are a high energy, hands-on team leader able to lead and grow a team across multiple locations. You have a proven track record of driving profitable growth and deep experience managing P&Ls. You are a deep expert in the freight forwarding market and processes, able to guide your team on how to execute as well as interact with our software engineering team on building a best-in-class forwarding product.  

What You'll do

Set and implement the strategy for air freight in your region.

• Set the financial targets (volume, revenue, net revenue, gross profit, etc…) working hand in hand with Sales, Finance and Regional Air leadership
• Develop the strategy and tactics to execute against your Annual Operating Plan (AOP).
• End-to-end ownership of country P&L including gross revenue, COGS, net revenue and operating expenses. By leveraging your core value drivers of procurement, pricing, planning and business development you will fuel growth.
• Ownership of all operational metrics for your region including on-time performance, schedule quality, productivity
• Drive day-to-day the implementation of your region’s strategy, ensuring you have the right metrics in place to track performance, that objectives are well cascaded within your teams and steering execution against agreed initiatives
• Ensure we have regular reporting of progress against plan and promote visibility to the executive leadership of the company

Develop and execute your country’s procurement strategy for all trades

• Identify procurement opportunities and lead strategic negotiations to secure the most value.
• Administer a clear vendor strategy for the region identifying which airlines, handlers, and truckers we should leverage; establish service level agreements; and administer rigorous performance management.
• Formalize a long-term vision on where we want to procure ourselves vs. use a third-party forwarder and maintain an implementation roadmap.
• Establish and maintain executive-level relationships with key contacts at airlines domiciled in the region.
• Constantly monitor our end-to-end procurement cost vs. market and ensure the team continuously drives improvements in our overall competitiveness

Drive product development by building service capabilities for Flexport air in your region

Align regional product capabilities with the market by partnering closely with regional operations on end-to-end service level agreement standardization. 

• Develop new products when gaps persist. You are identifying market needs and building end-to-end solutions to bring Flexport to market parity or exceed market expectations. 
• Operations leadership on product quality, driving best-in-class quality as measured by on-time performance, schedule quality, and other metrics as defined 
• Partner with our product and engineering teams to identify product and feature gaps. You act as a business partner to them and provide subject matter expertise in order to establish product requirements and product roadmap.  

Lead and develop a high-performing air freight team

• Define the target organization required to meet the regional strategic goals working hand in hand with Sales and Finance.
• Recruit and develop a high-performing Air Management team partnering closely with other cross-functional teams such as sales and account management. 
• Ensure team objectives and individual objectives are in place for each team member and actively manage the team engagement, performance and growth
• Lead the team through the frequent transformations and re-organizations required in a high growth company, ensuring they constantly embrace change while maintaining a high performance
• Be a role model for Flexport values

Partner with Sales Organization to drive go-to-market strategies and lead pricing strategy

• Drive strong collaboration between Demand teams and the regional air team to design and implement the best end to end products for our customers.
• Ensure your team provides deep market expertise, operations expertise, technological expertise and consultative sales support to the sales organization to grow our book of business in your region. 
• Ensure market intelligence, as well as sales collateral on products, are properly formalized and disseminated.  Enable the Demand teams on selling all air products. 
• Drive pricing strategy, leveraging key metrics such as conversion rates. You set the tone for how we price, leading markup management strategies for trade-lanes and customer segmentation while also spearheading investment decisions for strategic accounts. 

What You should have

• 10+ years of experience at a freight forwarder, airline or in logistics operations
• Experience on procurement, and airline relationships out of the Taiwan market.
• Hands on leader with experience managing and motivating large diverse team and implementing large scale organizational transformations
• Strategic thinker and very strong day to day implementer
• Deep freight forwarding market and freight forwarding operations expertise. Previous experience in leadership role in freight forwarding operations a plus
• Inclination to think-outside-the-box to always find a better solution or alternative, while remaining grounded in numbers and metrics
• Excel to manage vendor relations and create best-in-class, innovative structures to do so
• Excellent communication, interpersonal and organizational skills
• A client service mindset; you are obsessed with client and squad happiness
• Next-level attention to detail, love to dive deep in all operational processes

About the Role

The Verkada Team is seeking a Fulfillment Specialist to join our Fulfillment team in Taiwan! We are looking for a self-starter to support our global Operations and Sales teams. This opportunity requires an experienced individual with excellent problem-solving abilities, high attention to detail, and a can-do attitude!

What You’ll Do

• Communicate order and return status updates to customers and internal stakeholders via email, phone, and in person.
• Process incoming orders, validate purchase order contents are accurate, engage with our warehouses to ensure timely dispatch.
• Process incoming returns from our customers and warehouse. This includes receiving, categorizing, and initiating refurbishment process.
• Work with the larger operations (Global Operations, Supply Chain) team to support inbound and outbound shipments, escalations and exceptions.
• Collaborate with Finance on various returns / orders issues.
• Take on other projects and tasks to help support Verkada operations

What You Bring 

• +2 years minimum experience in a call center setting
• Email handling and order entry experience in high volume environment
• Proficient with both written and verbal communication (email, phone, in person). Knowledge of email etiquette is required
• Ability to complete tasks and projects independently with minimal supervision, requiring self-discipline, self-motivation, and ability to manage time effectively
• Strong attention to detail, comfortable working in fast-paced startup environment, and team player with positive attitude
• Must be able to pass a customer service assessment
• Netsuite and Salesforce experience (not required, but a plus)
• Ability to work 7:00AM-4:00PM Taipei time
• Bachelor's Degree preferred

Taiwan Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Private medical insurance by Nan Shan Life Insurance
• Permanent employees of Verkada Taiwan are eligible for full participation to the group insurance scheme, including accidental death and dismemberment, critical illness, accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Spouses and immediate dependents are eligible to participate in the scheme for accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, flexible PTO and personal sick time
• Professional development stipend
• Wellness/fitness benefits
• Meal stipend
• Commuter benefits

Additional Information

• You must be independently authorized to work in Taiwan. We are unable to sponsor or take over sponsorship of an employment visa for this role, at this time.

About the Role

As a member of our Hardware team, you will lead the design and development of Verkada products. Verkada’s Hardware Engineers own all aspects of electrical engineering and validation, working directly with our JDM partners to ship cutting-edge products. This is a full-time, in-person role based in our Taipei, Taiwan office.

What You'll Do

• Lead electrical engineering for new products from initial proof of concept through to mass production.  
• Collaborate with an international team of hardware engineers, mechanical engineers, industrial designers, and product managers to develop new products.  
• Own component selection, schematic and layout development based on the architecture you have created.  
• Quickly prototype new product concepts for mock-up builds and proof of concept studies.  Get hands-on with board bring-up, debug, testing and validation.  
• Build and execute robust test plans by leveraging resources at our JDM/ODM partners.  Lead root cause analysis efforts related to EMC, surge, thermal, RF testing and more.  
• Lead JDM teams to efficiently and effectively complete programs.  Work closely with manufacturing partners to steer hardware designs through design and validation builds (EVT, DVT, PVT) and into mass production. 
• Work on-site with manufacturing partners to review designs, run experiments, and troubleshoot issues in our factories. 
• Lead compliance / regulatory efforts for relevant hardware products.

What You Bring

• BS in Electrical Engineering.  
• Strong technical knowledge of electrical design that meet compliance requirements, validation and manufacturing.  
• 8+ years of experience in developing and manufacturing new electronics products.  
• Exposure to EMC & safety related standards
• Experience with analog audio circuitry 
• Excellent communication skills.  Fluency in English and Mandarin.
• Flexible and adaptive in a fast-paced startup environment.
• Experience working with US teams & an international supply chain.
• Ability to travel internationally up to 20%.

Taiwan Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Private medical insurance by Nan Shan Life Insurance
• Permanent employees of Verkada Taiwan are eligible for full participation to the group insurance scheme, including accidental death and dismemberment, critical illness, accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Spouses and immediate dependents are eligible to participate in the scheme for accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, flexible PTO and personal sick time
• Professional development stipend
• Wellness/fitness benefits
• Meal stipend
• Commuter benefits

Additional Information

• You must be independently authorized to work in Taiwan. We are unable to sponsor or take over sponsorship of an employment visa for this role, at this time.

About the Role

As a Structural Packaging Designer on Verkada’s Industrial Design Team, you’ll design and develop packaging solutions for cameras, access control systems, alarms, sensors, intercoms, and their associated accessories alongside our growing team of designers and hardware engineers. You will provide creative vision from initial concept through to mass production. You’ll maintain and evolve Verkada’s packaging design language by creating systems & solutions that emulate our core brand principles, effectively protect our award-winning products, and deliver premium experiences for our customers. You’ll make a big impact — your designs will be a part of Verkada’s quickly expanding portfolio of products.

Responsibilities

• Influence the visual and physical language of our brand through the design, engineering, quality assurance and out-of-box-experience of our packaging.
• Utilize user-centric thinking and keen aesthetic sensibility to align our brand to customer needs.
• Work collaboratively with design, engineering, manufacturing partners, and operations on complex technical programs in a fast-paced environment.
• Drive and influence the development of Verkada packaging sustainability initiatives.
• Conceive elegant, effective ways to address manufacturing & structural packaging challenges.
• Design and implement systems for packaging across a broad range of products in varying materials, weights, shapes, and sizes. 
• Support the Visual Design team with packaging labels and graphic creation.
• Conduct on-site press checks to review printed material for quality, accuracy, and color balance. Previous experience or desire to learn this skill set is preferred.
• Collaborate with international vendors and manufacturing partners to define, specify, and confirm packaging designs for production.
• Create detailed documentation for inspection criteria, limit samples, and packout procedures to guide our manufacturing partners.
• Maintain or advance packaging standards through on-site validation and ISTA test results.
• Represent the greater Industrial Design Team during vendor visits and QA audits. 
• Effectively present design concepts and strategy to peers and key stakeholders.

Requirements

• A website or digital portfolio containing case studies in mass-produced packaging solutions or systems.  
• Bachelor's degree in Packaging Design, Industrial Design, Packaging Engineering, or related field.
• 1-3 years of experience developing consumer or enterprise electronic product packaging solutions.
• Proficient in 2D and 3D structural packaging design tools such as Solidworks, Creo, ArtiosCAD, Keyshot, Adobe Creative Suite, etc.
• Self-motivated, detail-oriented, and effective at collaborating across global teams in both the US (PST) and SE Asia time zones.
• Strong communication and project management skills to work directly with packaging vendors and JDM/OEM partners in navigating tight schedules for multiple packaging projects.
• Ability to identify new packaging processes to improve efficiencies and reduce costs.
• A strong understanding of manufacturing methods, processes, and ecological impact of various substrates such as corrugated structures, molded fibers, PCR plastics, and printing techniques.
• Excellent communication skills. Fluency in English and Mandarin.
• Experience with reliability testing (ISTA) & quality assurance.
• Ability to travel up to 25%.

Nice to Have

• Startup experience with a quick-to-market mentality.
• Experience in business-to-business (B2B) transaction models, product trials, and refurbishment procedures.

Taiwan Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Private medical insurance by Nan Shan Life Insurance
• Permanent employees of Verkada Taiwan are eligible for full participation to the group insurance scheme, including accidental death and dismemberment, critical illness, accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Spouses and immediate dependents are eligible to participate in the scheme for accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, generous time off, and personal sick time
• Professional development stipend
• Wellness/fitness benefits
• Meal stipend
• Commuter benefits

What You'll Do

• Drive new products from initial proof of concept through to mass production
• Generate mechanical solutions for a wide variety of product requirements relevant to enterprise hardware (mounting, sealing, environmental resistance, thermals, tamper resistance, audio systems etc.)
• Collaborate with our Electrical Engineering team to integrate PCBAs, sensors, interconnects, and other electro-mechanical elements into your designs
• Collaborate with our Industrial Design team to explore, prototype, test new product concepts, and finalize product form and CMF
• Work with mechanical vendors to dial in DFM/DFA, then quote & kick-off parts at prototype and production quantities
• Own tooling release, bring up, and validation for a broad variety of parts & processes
• Develop, manage & execute mechanical reliability test plans and various DoEs
• Assist with failure analysis and root cause analysis; troubleshoot, iterate, and validate quickly  
• Work closely with our JDM and CM partners to steer your product concepts through validation builds (EVT, DVT, PVT) & into mass production
• Drive on-site factory troubleshooting, assembly line bring-up, and root cause analysis
• Outdoor product design experience (IP66/67, IK08/10)

What You'll Bring

• B.S. in Mechanical Engineering or related fields
• Excellent written and verbal English & Mandarin communication skills
• A clear track record of designing and manufacturing enterprise or consumer electronic products (8+ years of experience)
• Mastery of 3D CAD software
• Experience getting hands-on with building & testing hardware
• Ability to frequently visit vendors throughout Taiwan and Southeast Asia 
• Experience working with part vendors on DFM, tooling bring up and validation
• Passion for designing aesthetically pleasing but easy to use hardware

What You'll Do

• Oversee key EVT, DVT and PVT build milestones at our JDM R&D and factory facilities. Leverage your engineering expertise to de-risk NPI builds and expedite technical troubleshooting independently. 
• Own manufacturing readiness, line bring up, and FATP problem solving for a complex set of electromechanical products within one of Verkada’s newest product lines. 
• Guide material readiness, fixture/jig readiness, and other clear to build efforts in advance of FATP. Coordinate between JDM manufacturing partners and internal firmware team to assess FATP flow, test coverage, fixture/equipment plans and associated test limits.
• Work closely with EE, ME and FW teammates (in both the US and Taiwan) to solve a variety of end to end NPI challenges from early design development efforts to later stage validation & compliance challenges.
• Work closely with EPM teammates to drive vendors towards aggressive schedules and ambitious objectives; hold our manufacturing partners accountable & communicate status updates clearly to EPM counterparts & the broader team. 
• Serve as a key point of contact for an international network of manufacturing partners.

What You Bring

• B.S. in Electrical Engineering 
• Strong technical knowledge of electromechanical design, validation and manufacturing test and test fixture development. 
• 5+ years of experience developing and manufacturing new electronics products.
• Direct exposure to manufacturing of audio & video related products is a plus. 
• Must have completed at least two full hardware development cycles through product launch with direct (in person) exposure to FATP
• Excellent organizational skills and written and verbal communication
• Fluency in both Mandarin and English 
• Flexible and adaptive in a fast-paced startup environment
• Ability to travel internationally up to 30%

About the Role

As a Visual Production Designer at Verkada, you will bring our brand to life through high-quality packaging, labels, and production-ready visual assets that ship at global scale. You’ll drive consistency and precision across our growing portfolio by creating and managing production files, overseeing proofing and print processes, and partnering directly with vendors to resolve issues and improve workflows. Your work will have a direct impact on Verkada's brand through the user experience and the logistical workings of our global supply chain, through clear and consistent labelling, helping scale Verkada’s hardware platform while upholding exceptional design and quality standards.

What You'll Do

• Create scalable printed and digital assets that reinforce our visual language and company values, which can be adapted across Verkada's diverse portfolio.
• Collaborate with industrial design and hardware engineering teams to create clean, consistent packaging and label artwork.
• Prepare production-ready files and oversee proofing and production processes to ensure accuracy and quality.
• Manage vendor communications by providing clear artwork and dieline specifications, coordinating feedback, and resolving production issues.
• Conduct vendor site visits and press checks to review proofs, validate materials, and address production challenges.
• Evaluate production samples for color, material, and print accuracy, documenting results and driving corrective actions.
• Develop and manage design libraries and define specifications for creatives to work against.
• Identify, document, and implement process improvements across creative, production, and vendor workflows to increase efficiency and quality at scale.
• Manage multiple priorities and adhere to tight schedules while upholding high design standards.

What You Bring

• A website or digital portfolio with examples of visual design for hardware and/or packaging assets is required for consideration.
• Bachelor's degree in Design or a related field.
• 3+ years of experience as a Production Designer for Visual Design
• Experience with high-volume print production processes.
• Excellent communication skills in both English and Mandarin.
• Consistency in visual composition with high attention to detail.
• Extensive knowledge of typography and graphic design conventions.
• High level of organization and communication skills to support collaborators across the organization with assets and clear directives.
• Proficient in 2D digital tools like Adobe Illustrator, Photoshop, etc.
• Thorough understanding of manufacturing processes and production timelines.
• Ability to generate and communicate vision, or embrace and extend existing solutions.
• Ability to travel internationally up to 15% of the time.

Nice to Have

• Experience tuning artwork applications on 3D surfaces across different materials (i.e. pad printing, laser etching, etc.)
• Experience working in enterprise or consumer electronics.
• Experience working with graphic requirements for electronic product certifications, like UL, CE, etc.

Taiwan Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Private medical insurance by Nan Shan Life Insurance
• Permanent employees of Verkada Taiwan are eligible for full participation to the group insurance scheme, including accidental death and dismemberment, critical illness, accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Spouses and immediate dependents are eligible to participate in the scheme for accident medical reimbursement, hospital and surgical, and cancer indemnity cover
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, generous time off, and personal sick time
• Professional development stipend
• Wellness/fitness benefits
• Meal stipend
• Commuter benefits

Additional Information

• You must be independently authorized to work in Taiwan. We are unable to sponsor or take over sponsorship of an employment visa for this role, at this time

Cresta is on a mission to turn every customer conversation into a competitive advantage by unlocking the true potential of the contact center. Our platform combines the best of AI and human intelligence to help contact centers discover customer insights and behavioral best practices, automate conversations and inefficient processes, and empower every team member to work smarter and faster. Born from the prestigious Stanford AI lab, Cresta's co-founder and chairman is Sebastian Thrun, the genius behind Google X, Waymo, Udacity, and more. Our leadership also includes CEO, Ping Wu, the co-founder of Google Contact Center AI and Vertex AI platform, and co-founder, Tim Shi, an early member of Open AI.

Join us on this thrilling journey to revolutionize the workforce with AI. The future of work is here, and it's at Cresta.

About the role:

At Cresta, the AI Agent team is on a mission to create state-of-the-art AI Agents that solve practical problems for our customers. We are focused on leveraging the latest technologies in Large Language Models (LLMs) and AI Agent systems, while ensuring that the solutions we develop are cost-effective, secure, and reliable. 

As an AI Agent Engineer, you'll be at the forefront of deploying AI agents that address real-world challenges. In this role, you will work closely with customers as well as our software and machine learning engineers, ensuring high-impact AI Agent deployments and contributing to the continuous improvement of our core AI platform. You’ll develop intelligent AI agents, integrate them seamlessly with external systems and offer hands-on technical expertise to ensure successful deployments.. This position requires strong engineering skills, adaptability, and customer engagement. If you are self-driven, analytical, and eager to leverage AI in practical applications, this role is for you.

What You'll Do :

• AI Agent Development: Develop, configure, deploy, and optimize AI agents using Cresta’s AI platform and tools.
• System Integration: Build AI agent integrations with external systems (APIs, databases, CRMs, etc.) to ensure seamless workflow integration.
• Performance Optimization: Optimize AI agent performance (e.g. fine-tune prompts and configurations) and troubleshoot issues in complex enterprise environments.
• Requirements Gathering: Collaborate with customers and internal stakeholders to gather technical requirements and translate business needs into AI Agent solutions.
• Demos & Iteration: Conduct interactive demos and present compelling proof-of-concepts to prospective customers, proactively gather feedback, and iteratively refine solutions to meet objectives.
• Project Coordination: Define project milestones, create implementation plans, and coordinate execution with internal teams to ensure on-time delivery. Provide a tight feedback loop to our product and engineering teams — identifying gaps, building custom tooling, and influencing the roadmap through real-world deployment learnings.
• Partner Cross-Functionally: Collaborate with PMs to define agent goals, iterate rapidly based on customer feedback, and shape product capabilities that maximize customer ROI.
• Technical Guidance: Serve as a trusted technical advisor for the customer, guiding best practices for AI agent adoption and usage. Provide technical guidance on AI agent best practices, including architecture design, security considerations, and scalability planning.

What We're Looking For:

• Education: Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field.
• Experience: 3+ years of full-time working experience in software development/Consulting, AI/ML engineering, or Forward Deployed Engineering.
• Programming Skills: Proficiency in Python and Golang, with the ability to write clean, efficient code.
• AI/ML Knowledge: Familiarity with AI/ML concepts. Hands-on experience with large language models (LLMs), and prompt engineering techniques are strongly preferred.
• AI Agent Frameworks: Strong understanding of general AI agent frameworks, function calling, and retrieval-augmented generation (RAG). Hands-on experience of building such a system is strongly preferred.
• Cloud & DevOps: Experience with cloud platforms (AWS, GCP, or Azure) and DevOps practices (CI/CD, containerization, monitoring).
• Integration Expertise: Hands-on experience with integrating systems via APIs, webhooks, and data pipelines.
• Communication: Excellent communication and project management skills.
• Analytical Approach: Ability to use data-driven decision-making, including A/B testing and performance monitoring, to refine solutions.
• Collaborative Builder: You thrive in cross-functional environments, working hand-in-hand with PMs and engineers to turn real customer problems into scalable AI solutions.

Perks & Benefits:

We offer a comprehensive and people-first benefits package to support you at work and in life:

• We offer Cresta employees a variety of medical benefits designed to fit your stage of life
• Flexible vacation time to promote a healthy work-life blend
• Paid parental leave to support you and your family

Compensation at Cresta 

Cresta’s approach to compensation is simple: recognize impact, reward excellence, and invest in our people. We offer competitive, location-based pay that reflects the market and what each individual brings to the table.

The posted base salary range represents what we expect to pay for this role in a given location. Final offers are shaped by factors like experience, skills, education, and geography. In addition to base pay, total compensation includes equity and a comprehensive benefits package for you and your family.

We have noticed a rise in recruiting impersonations across the industry, where scammers attempt to access candidates' personal and financial information through fake interviews and offers. All Cresta recruiting email communications will always come from the @cresta.ai domain. Any outreach claiming to be from Cresta via other sources should be ignored.  If you are uncertain whether you have been contacted by an official Cresta employee, reach out to recruiting@cresta.ai 

Toast creates technology to help restaurants and local businesses succeed in a digital world, helping business owners operate, increase sales, engage customers, and keep employees happy.

Operations Program Management (OPM) Team

Toast is driven by building the restaurant platform that helps restaurants adapt, take control, and get back to what they do best: building the businesses they love. As we scale our hardware operations, we are looking for a dedicated Materials Program Manager/Analyst to provide deep supply chain visibility, materials oversight, and financial reporting support for our OPM team — allowing our broader operations team to stay focused on strategic execution and uninterrupted supply continuity.

A day in the life (Responsibilities) 

• Supply Chain Tier Management: Partner with CMs on Clear-to-Build (CTB) analysis and provide visibility into materials supply, projected coverage, and constraints across supply chain tiers.
• Allocation Strategy & Reconciliation: Develop data-driven allocation strategies for supply-constrained environments and standardize material allocations between Toast and CM vendors to prevent shortfalls and miscommunications.
• Non-Standard Process & Inventory Oversight: Manage protocols for consigned inventory and non-standard material handling, including coordination of shipments, POs, and reconciliation for high-value components sourced through third-party brokers.
• Excess & Obsolete (E&O) Risk Management: Proactively identify E&O inventory risks and present mitigation plans to leadership; support EOL transitions and next-generation component integration roadmaps.
• Financial Reporting & Analytics: Act as the primary liaison for material reporting needs from Finance and Accounting, maintaining dashboards that provide cross-organizational visibility including PO cost tracking.
• Cross-Functional Alignment: Drive alignment with Demand Planning and Strategic Sourcing to optimize material allocation, reduce procurement costs, and support supply/demand decision-making.
• Work mode: Hybrid (2-3 days in Office)

What you'll need to thrive (Requirements)

• 5+ years of experience in supply chain, materials management, or operations within the semiconductor, PCBA, or contract manufacturing industry
• Demonstrated experience managing consigned inventory, third-party broker relationships, and multi-party purchase order coordination
• Proficiency in CTB analysis, materials planning, and supply/demand modeling
• Strong background in financial reporting and cross-functional collaboration with Finance and Accounting teams
• Experience developing allocation strategies in supply-constrained environments across multiple programs or lines of business
• Proven ability to identify and mitigate E&O and EOL risks at scale
• Excellent analytical skills with experience building and maintaining supply chain dashboards and reporting tools
• Strong communicator with the ability to synthesize complex materials data for both operational and executive audiences

Special Sauce (Nice to Haves)

• Experience working with memory components (DRAM, NAND) and familiarity with memory supply chain dynamics
• Background supporting hardware or IoT product supply chains
• Familiarity with Contract Manufacturing relationships
• Experience in a high-growth technology company managing supply chain complexity at scale
• Proficiency with ERP systems (e.g., SAP, Oracle) and supply chain analytics tools

AI at Toast

At Toast, one of our company values is that we're hungry to build and learn. We believe learning new AI tools empowers us to build for our customers faster, more independently, and with higher quality. We provide these tools across all disciplines, from Engineering and Product to Sales and Support, and are inspired by how our Toasters are already driving real value with them. The people who thrive here are those who embrace changes that let us build more for our customers; it’s a core part of our culture.

Our Total Rewards Philosophy 
We strive to provide competitive compensation and benefits programs that help to attract, retain, and motivate the best and brightest people in our industry. Our total rewards package goes beyond great earnings potential and provides the means to a healthy lifestyle with the flexibility to meet Toasters’ changing needs. Learn more about our benefits at https://careers.toasttab.com/toast-benefits.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a Senior/Clinical Research Associate. 

Position Summary:

The CRA provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience for CRAII; 1 year oncology and Phase I experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a Senior/Clinical Research Associate. 

Position Summary:

The CRA provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience for CRAII; 1 year oncology and Phase I experience preferred. 

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Position Summary:

The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

PM will either manage regional trials (moderate complexity) and/or supportive role in managing complex global trials. The essential functions below will describe the PM acting in a primary / lead PM role on a study. When in a supportive role on a global study, the essential functions will be delegated by the Global Lead.

Essential functions of the job include but are not limited to:
• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversees all functional services including external vendors to the established timeline and budget
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. • Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly.
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• Lead both internal and client meetings and set expectations for the project team
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
• Support business development and marketing activities as appropriate, including travel to Bid Defence meetings as required
• Perform other duties as assigned by management
• Remain compliant with organisational training, time-reporting and any other administrative duties as required
• Provides on-going feedback for functional team members including annual performance reviews
• Ability to travel domestically and internationally including overnight stays

Qualifications:
Minimum Required:
• Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 4-7 years of clinical research experience or proven competencies for this position and a minimum of 2-4 years of leading a project
• Experience managing regional trials (moderate complexity) and/or supportive role in managing complex global trials

Other Required:
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project,eTMF, EDC and CTMS
• Good communication and interpersonal skills to effectively interface with others in a team setting
• Good organizational skills, attention to detail, and a customer service demeanor

• Mandarin Speaking as this is required to cover East Asia market

Competencies:
• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items
• Working knowledge of project management techniques and tools
• Experience working in a cross-functional project management environment
• Fundamental understanding of cross-functional management
• Fundamental understanding of project planning, risk management and change management with an awareness of appropriate escalation
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a study team
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Good time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Good presentation, verbal and written communications skills
• Fundamental understanding of project management software
• Experience in pharmaceutical and/or device research required

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.

• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site 
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form. 
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English. 

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. 
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site 
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form. 
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English. 

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. 
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an CRA II (based in Shanghai and Beijing or Taiwan)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.

Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

We are hiring for Project Support Specialist.

The Project Support Specialist serves as a member of the project team providing cross-functional support with the goal of contributing toward efficient management of the studies to which they are assigned. The PSS is a solid team member who can execute, with some oversight, all core responsibilities consistently across several studies using independent judgment and critical thinking. The PSS effectively collaborates with their cross-functional team members and will take on new or expanded responsibilities when appropriate and with proper training. The PSS II prioritizes their work and collaborates with the project team to ensure a consistent understanding of the timing for completion of work products.

Essential functions of the job include but are not limited to:

• Manages the meeting lifecycle including scheduling internal and external meetings, preparing, and circulating agendas, taking meeting minutes, circulating, and updating meeting minutes based on team member input, and filing meeting agendas and minutes in the Trial Master File.
• Assists with creation and maintenance of the project timeline in MS Project or similar system. Collects updates from team members, captures and documents these updates, and ensures updates are communicated to the cross-functional study team.
• Performs an array of activities and tasks in clinical systems applicable to their role and project scope.
• Manages study-specific training lifecycle by collecting, tracking, and loading training materials, assigning team members to appropriate training, and documenting completion of study-specific training in appropriate systems. Manages the maintenance of training records and files records in the Trial Master File.
• Identifies gaps in training by reviewing team member training compliance on a defined periodic basis and engages appropriate team members to ensure training completeness. Escalates to the Project Manager as needed.
• Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors, and others as appropriate.
• Creates project-specific email boxes and maintains appropriate access to study team members.
• Manages user access to study systems by submitting user requests to the Helpdesk or similar, by reviewing team member access on a defined periodic basis, and documenting access reviews. Ensure rapid removal of system access for team members no longer affiliated with the study.
• Orders study supplies and addresses queries on study supplies.
• Prepares study binder materials and works with vendor to ensure proper binder creation and shipping to study sites. Works with vendor to obtain project-related cost estimates. Ensures vendor quotes align with invoices for completed binders and consults directly with Project Manager to approve vendor payments.
• Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager, or other project leader.
• Manages the addition and removal of project team members in the finance system, including assignment of team members to specific tasks for time tracking.
• Reviews and approves weekly time reporting by team members. Identifies and escalates time reporting concerns to the Project Manager.
• With oversight by the Safety Lead, supports the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable.
• Manages the translation of site level documents, as applicable, per local and regional standards through document collection, tracking, vendor collaboration, engagement of stakeholders to evaluate translation completeness and vendor payments.
• Supports the management of project-specific vendors by assisting with development of the Vendor Management Plan, providing vendors with project trainings and access to systems, tracking vendor issues and overseeing vendor invoicing and payments.
• Manages the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
• Supports the Project Manager with the production of various study plans, reports and updates (e.g., PM plan, country/site initiation, activation, recruitment) including preparing initial drafts, managing the collection of team member input, and finalizing content.
• Collects data and maintains monthly Key Performance Indicators (KPIs) and project health data. Circulates data to the Project Manager and internal team members as appropriate.
• Collects functional team input for the quarterly inspection readiness review.
• May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
• Supports the Project Manager in the creation and maintenance of the Sponsor-facing study story board.
• Supports the Project Manager in tracking out of scope work. Prepares, with guidance, materials required for the submission of change orders.
• Performs other duties as assigned by the Project Manager.

Qualifications:

Minimum Required:

• 4-year college degree or international equivalent; or equivalent experience ideally in a business, scientific or healthcare discipline
• Minimum 2 years relevant experience or demonstrated competencies in the key requirements of the role.

Other Required:

• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
• Ability to communicate both verbally and in writing at the English proficiently.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

We are hiring for Project Support Specialist.

The Project Support Specialist serves as a member of the project team providing cross-functional support with the goal of contributing toward efficient management of the studies to which they are assigned. The PSS is a solid team member who can execute, with some oversight, all core responsibilities consistently across several studies using independent judgment and critical thinking. The PSS effectively collaborates with their cross-functional team members and will take on new or expanded responsibilities when appropriate and with proper training. The PSS II prioritizes their work and collaborates with the project team to ensure a consistent understanding of the timing for completion of work products.

Essential functions of the job include but are not limited to:

• Manages the meeting lifecycle including scheduling internal and external meetings, preparing, and circulating agendas, taking meeting minutes, circulating, and updating meeting minutes based on team member input, and filing meeting agendas and minutes in the Trial Master File.
• Assists with creation and maintenance of the project timeline in MS Project or similar system. Collects updates from team members, captures and documents these updates, and ensures updates are communicated to the cross-functional study team.
• Performs an array of activities and tasks in clinical systems applicable to their role and project scope.
• Manages study-specific training lifecycle by collecting, tracking, and loading training materials, assigning team members to appropriate training, and documenting completion of study-specific training in appropriate systems. Manages the maintenance of training records and files records in the Trial Master File.
• Identifies gaps in training by reviewing team member training compliance on a defined periodic basis and engages appropriate team members to ensure training completeness. Escalates to the Project Manager as needed.
• Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors, and others as appropriate.
• Creates project-specific email boxes and maintains appropriate access to study team members.
• Manages user access to study systems by submitting user requests to the Helpdesk or similar, by reviewing team member access on a defined periodic basis, and documenting access reviews. Ensure rapid removal of system access for team members no longer affiliated with the study.
• Orders study supplies and addresses queries on study supplies.
• Prepares study binder materials and works with vendor to ensure proper binder creation and shipping to study sites. Works with vendor to obtain project-related cost estimates. Ensures vendor quotes align with invoices for completed binders and consults directly with Project Manager to approve vendor payments.
• Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager, or other project leader.
• Manages the addition and removal of project team members in the finance system, including assignment of team members to specific tasks for time tracking.
• Reviews and approves weekly time reporting by team members. Identifies and escalates time reporting concerns to the Project Manager.
• With oversight by the Safety Lead, supports the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable.
• Manages the translation of site level documents, as applicable, per local and regional standards through document collection, tracking, vendor collaboration, engagement of stakeholders to evaluate translation completeness and vendor payments.
• Supports the management of project-specific vendors by assisting with development of the Vendor Management Plan, providing vendors with project trainings and access to systems, tracking vendor issues and overseeing vendor invoicing and payments.
• Manages the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
• Supports the Project Manager with the production of various study plans, reports and updates (e.g., PM plan, country/site initiation, activation, recruitment) including preparing initial drafts, managing the collection of team member input, and finalizing content.
• Collects data and maintains monthly Key Performance Indicators (KPIs) and project health data. Circulates data to the Project Manager and internal team members as appropriate.
• Collects functional team input for the quarterly inspection readiness review.
• May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
• Supports the Project Manager in the creation and maintenance of the Sponsor-facing study story board.
• Supports the Project Manager in tracking out of scope work. Prepares, with guidance, materials required for the submission of change orders.
• Performs other duties as assigned by the Project Manager.

Qualifications:

Minimum Required:

• 4-year college degree or international equivalent; or equivalent experience ideally in a business, scientific or healthcare discipline
• Minimum 2 years relevant experience or demonstrated competencies in the key requirements of the role.

Other Required:

• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
• Ability to communicate both verbally and in writing at the English proficiently.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

As our organisation continues to grow we are delighted to be expanding our business in Asia Pacific and are now looking for a Senior Clinical Data Manager.

Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Requirement :
• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills

• Systems knowledge with Medidata Rave and Veeva
• Ability to undertake occasional travel

Preferred:

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience
• Knowledge of Biostatistics

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

As our organisation continues to grow we are delighted to be expanding our business in Asia Pacific and are now looking for a Senior Clinical Data Manager.

Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Requirement :
• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills

• Systems knowledge with Medidata Rave and Veeva
• Ability to undertake occasional travel

Preferred:

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience
• Knowledge of Biostatistics

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

As our organisation continues to grow we are delighted to be expanding our business in Asia Pacific and are now looking for a Senior Clinical Data Manager.

Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Requirement :
• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills

• Systems knowledge with Medidata Rave and Veeva
• Ability to undertake occasional travel

Preferred:

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience
• Knowledge of Biostatistics

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

As our organisation continues to grow we are delighted to be expanding our business in Asia Pacific and are now looking for a Senior Clinical Data Manager.

Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Requirement :
• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills

• Systems knowledge with Medidata Rave and Veeva
• Ability to undertake occasional travel

Preferred:

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience
• Knowledge of Biostatistics

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an Senior / CRA  (based in HongKong)

Position Summary:

The CRA  provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Position Summary:

The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

PM will either manage regional trials (moderate complexity) and/or supportive role in managing complex global trials. The essential functions below will describe the PM acting in a primary / lead PM role on a study. When in a supportive role on a global study, the essential functions will be delegated by the Global Lead.

Essential functions of the job include but are not limited to:
• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversees all functional services including external vendors to the established timeline and budget
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. • Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly.
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• Lead both internal and client meetings and set expectations for the project team
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
• Support business development and marketing activities as appropriate, including travel to Bid Defence meetings as required
• Perform other duties as assigned by management
• Remain compliant with organisational training, time-reporting and any other administrative duties as required
• Provides on-going feedback for functional team members including annual performance reviews
• Ability to travel domestically and internationally including overnight stays

Qualifications:
Minimum Required:
• Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 4-7 years of clinical research experience or proven competencies for this position and a minimum of 2-4 years of leading a project
• Experience managing regional trials (moderate complexity) and/or supportive role in managing complex global trials

Other Required:
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project,eTMF, EDC and CTMS
• Good communication and interpersonal skills to effectively interface with others in a team setting
• Good organizational skills, attention to detail, and a customer service demeanor

• Mandarin Speaking as this is required to cover East Asia market

Competencies:
• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items
• Working knowledge of project management techniques and tools
• Experience working in a cross-functional project management environment
• Fundamental understanding of cross-functional management
• Fundamental understanding of project planning, risk management and change management with an awareness of appropriate escalation
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a study team
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Good time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Good presentation, verbal and written communications skills
• Fundamental understanding of project management software
• Experience in pharmaceutical and/or device research required

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.