Position 

We are seeking a talented, experienced, and highly motivated Clinical Trial Manager (CTM) to join our oncology Clinical Operations team. This role will require onsite presence a minimum of 3 days a week in our Millbrae, CA or Jersey City, NJ office to ensure effective global clinical trial management. The candidate must have the ability to work independently, be an effective leader, and an engaged clinical study team member in a dynamic, fast-paced environment.  You will play a key role in contributing to high quality in-house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and the successful completion of global clinical studies. 

This position requires proficiency in Mandarin, Cantonese, Japanese, or Korean and English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels). 

About You 

You have strong communication skills and are a collaborative, agile, detail oriented trial leader with global trial experience, and you have a passion for operational excellence and advancing patient care for grievous diseases. 

What You’ll Do 

• In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international in-sourced clinical trials, delivering high quality study data, on time and on budget 
• Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials 
• Collaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data. Ability to examine functional issues from a broader organizational perspective. 
• Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation 
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines 
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention 
• Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines 
• Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle 
• As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial 
• Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs) 
• Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements 
• Lead the creation and maintenance of all study files, including the study master file, and oversight of site files  
• Lead periodic review of the Sponsor Trial Master File

Qualifications 

• PhD and 3 years of relevant experience, or Masters Degree and 6 years of relevant experience, or Bachelors Degree and 8 years of relevant experience  
• Proven experience in Clinical Operations; Oncology trial management experience preferred 
• In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research 
• Demonstrated experience in managing and executing clinical trials from start-up to closeout 
• Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets 
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary 
• Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations 
• Proficiency in using Veeva clinical trial management systems (CTMS)  
• Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology
• Ability to work onsite at least 3 days a week

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.

Position

The Clinical Program Manager, Oncology, Clinical Study Management, will plan and oversee the execution of clinical trials in oncology and other therapeutic areas, as needed. This role  works in close partnership with cross-functional teams to ensure studies are delivered on time and within budget, with a strong focus on quality,  operational excellence, and best-in-class clinical study management. The successful candidate will play a key role in driving study execution, managing risks, and enabling high-performance collaboration across functions and regions.

This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. 

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience.

What You’ll Do

• Develop and own the operational strategy, timelines, and operational plans for clinical trials, ensuring alignment with program objectives and overall business goals.
• Oversee and lead cross-functional clinical trial execution, leading proactive risk identification, assessment, management, and driving alignment on mitigation strategies.
• Ensure high standards of quality by overseeing that clinical studies are conducted in accordance with approved protocols, company SOPs, applicable regulations, and maintain ongoing inspection readiness across the program lifecycle.
• Serve as central point of contact to facilitate cross functional team effectiveness, drive operational efficiency, and provide clear direction and guidance to ensure successful study execution.
• Work with minimal oversight from the Clinical Study Management Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development, Finance, and Legal functions.
• Oversee and manage vendor relationships and performance to ensure that clinical studies are completed in accordance with contractual specifications for quality, timelines, and cost.
• Provide regular, clear updates on study progress, risks, and mitigation plans to stakeholders and executive management (e.g., Clinical Study Management, Project & Portfolio Management, Clinical Research).
• Ensure that all study-related documents are accurate, complete, and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems in a timely manner.
• Lead, manage, hire, develop, and mentor global and regional Clinical Study Management personnel.
• Contribute to improvement initiatives, operational excellence efforts, and cross-functional projects that add value to Eikon Therapeutics.

Qualifications

• Bachelor’s degree with 8 years, a Master’s degree with 6 years, or a PhD with 3 years of relevant experience in life sciences, healthcare, or related field preferred. 
• Fluency in English (strong reading, writing, and speaking skills with the ability to effectively communicate with colleagues and stakeholders at all levels) is required.
• In-depth knowledge of ICH-GCP, regulations, directives, and guidelines.
• Proficiency in clinical trial management systems (CTMS, RTSM (IRT), Veeva Vault suite) and electronic data capture (EDC) systems.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience managing budgets, resources, processes and controls, productivity, quality, and project delivery.
• High sense of accountability and urgency to prioritize deliverables effectively.
• Growth mindset and ability to independently.
• PMP certification preferred.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.

Position: 

The Associate Director, Clinical Data Analytics and Reporting is a leader responsible for establishing and scaling a Clinical Research & Development clinical analytics function for a growing biotechnology company. This role will define the analytics strategy, operating model, and technology roadmap, including the technical implementation to enable high-quality, data-driven decision-making across Clinical Research & Development, with primary focus on oncology programs.  This is a hands-on role requiring demonstrated expertise in design, development, test and support of complete analytics & reporting system lifecycle. This leader will partner closely with Clinical Operations, Biostatistics, Data Management, Clinical Research, Regulatory, Safety and Clinical Quality Assurance to ensure proactive risk identification, operational excellence, inspection-ready execution across the portfolio. 

About You 

The successful candidate will combine deep clinical development expertise with advanced analytics, data governance, and visualization capabilities. The ideal candidate for this role should possess a proven track record of designing, implementing and supporting end-to-end data analytics solutions using current state-of-the-art technologies, and a deep knowledge of emerging trends and best practices in data analytics.  

What will you do: 

• Collaborate with Stakeholders in different areas of Clinical Development R&D organization, IT System Owners and external vendors to define and implement the clinical analytics vision, strategy and capabilities (e.g., dashboard, etc.) aligned with clinical development objectives. 
• Establish a scalable analytics operating model suitable for early stage through late phase development.
• Translate complex clinical and operational data into clear, actionable insights for executive and study teams (including predictive and prescriptive analytics to anticipate risks and optimize trial execution).
• Design, development, test and deployment of the complete end-to-end analytics solution to enable decision-grade dashboards and metrics across Clinical R&D.
• Design and implementation of datawarehouse/datalake/lakehouse including star schemas.
• Collaborate with System Owners, Business Owners and Subject Matter Experts to map sources system objects and attributes to data warehouse objects.
• Develop, test and support data pipelines for extract, transform, load (ETL) of the source system data to populate datawarehouse/datalake/lakehouse.
• Develop end user facing dashboards and analytics solutions.
• Support the operations of the IT systems landscape ensuring system uptime, ETL and other job completion as per schedule, ongoing system changes and enhancements. 

Qualifications 

• Post Graduate degree with 8+ years of experience or a Bachelor’s degree with 10+ years of experience in development and support of Clinical Operations analytics solutions.
• Demonstrated strong experience working with developing end user dashboards using solutions such as Qlik, Power BI, Shiny R/Python.
• Strong Experience developing datalake/lakehouse solutions on platforms such as Snowflake, Databricks, AWS, and Azure.
• Strong working knowledge of development and management of database technologies such as Postgres, SQLServer etc.
• Experience with development of data pipelines including ETL from source systems to datawarehouse/datalakes/lakehouse using solutions such as Apache Airflow, Fivetran, dbt etc.
• Excellent oral and written communication skills with high EQ to effectively collaborate with business cross-functional teams.
• Understanding of the clinical development lifecycle and demonstrated experience building analytics capabilities in clinical development
• Knowledge of Report/Dashboard development in Veeva R&D Vaults such Clinical, RIM, Quality, Safety is preferred.
• Knowledge of IT Computer System Validation (CSV) in a GxP environment is preferred.
• Experience with Automation and AI Agent Frameworks is preferred.
• Deep knowledge of RBQM, Quality by Design (QbD) and regulatory/operational expectations for clinical oversight is preferred. 

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $191,000 to $209,000 depending on skills, competency, and the market demand for your expertise.

Position

As a Clinical Trial Management Associate (CTMA), you will serve as a critical inhouse clinical operations partner in the execution, and oversight of Phase I–III global oncology clinical trials. Positioned between the Clinical Trial Associate (CTA) and Clinical Trial Manager (CTM), the CTMA brings increased ownership, autonomy, and judgment to the execution of clinical studies. You will independently manage assigned study responsibilities and help ensure the delivery of high-quality, compliant, and timely trial data in support of our mission to bring transformative therapies to patients.

This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.

This position requires fluency in one of the following languages due to the nature of site interactions in various regions in EMEA or LATAM: Portuguese, German, Italian, French, Polish. 

About You

You bring a strong operational mindset, an ability to work independently, and a flexible and collaborative spirit. You are looking to grow beyond a CTA role and take on more direct responsibility for study deliverables, bringing with you valuable clinical research experience and a strong passion to contribute meaningfully to drug development through consistent operational excellence.

What You’ll Do

• Proactively support Clinical Study Management team members in the day-to-day execution of global clinical trials, with increasing independence and accountability for specific study components. Collaborate closely with assigned global (gCSM)/regional Clinical Study Management (rCSM) teams, ensuring operational excellence throughout study execution.
• Manage and coordinate critical study activities with minimal oversight such as site communications, and maintenance of study timelines, risk logs, and action trackers.
• Lead the coordination and execution of site start-up assigned activities across multiple countries, working closely with regulatory, study start-up, and site engagement and monitoring excellence inhouse teams.
• Independently maintain and oversee trial master file (TMF) quality and completeness, in collaboration with TMF Operations, ensuring inspection readiness at all times.
• Draft, review, and manage study documents such as monitoring plans, training materials, and site communications under the guidance of the CTM.
• Track and reconcile investigational product (IP) and clinical supply/lab shipments, proactively flagging discrepancies and collaborating with supply chain to resolve issues.
• Support site level budget tracking invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance.
• Coordinate and contribute to key study meetings (e.g., team meetings, vendor meetings, investigator meetings), including agenda development, meeting facilitation, and action item follow-up.
• Monitor enrollment and site performance metrics, contributing to analysis and mitigation strategies to meet enrollment goals and drive operational excellence.
• Partner with data manager lead to ensure timely site follow up (assigned sites) for query reconciliation to meet the study milestones (e.g., interim analyses goals, etc.).
• Ensure compliance with study protocols, SOPs, and regulatory guidelines (e.g., ICH-GCP, FDA) across all operational activities.

Qualifications

• Bachelor’s degree with 3+ years of relevant clinical trial experience or a Master’s degree with 1–2 years of experience.
• Demonstrated ability to work independently and manage multiple competing priorities with minimal oversight.
• Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA).
• Experience using clinical systems such as CTMS, EDC, and eTMF; Veeva Vault experience is a plus.
• Excellent organizational and time management skills with high attention to detail.
• Strong written and verbal communication skills and ability to interact confidently with internal stakeholders and external partners.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project).
• Previous oncology trial experience preferred but not required.
• Working experience in LATAM/EMEA

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise.

Position

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology.

What You’ll Do

• Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans
• Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams
• Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions 
• Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted  following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents
• Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity
• Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial.
• Oversee the preparation and maintenance of detailed clinical trial project timelines
• Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality.
• Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones
• Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research)
• Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
• Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel.
• Contribute to initiatives and projects adding value to Eikon Therapeutics

Qualifications

• Minimum of 10 years of related experience with a Bachelor’s degree or 8 years and a post-graduate degree.
• Experience leading large, global clinical trials, preferably in oncology
• In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
• High sense of accountability and urgency to prioritize deliverables.
• Growth mindset and capable of working independently.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $183,000 to $199,500 depending on skills, competency, and the market demand for your expertise.

Position 

We are seeking a highly experienced, collaborative, and detail-oriented Contract Senior Manager capable of helping Eikon optimize its clinical Site Engagement and Monitoring function to support delivery of world class clinical drug development. The successful candidate will work closely with the Eikon Site Engagement and Monitoring Excellence (SEME) team, global Clinical Research Associates (CRAs) and internal study teams across therapeutic areas to oversee clinical site engagement and monitoring activities.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You have significant monitoring experience and a passion for leading, training, and mentoring CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to oversee monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You have experience developing systems, resources, and tools to support high-quality monitoring and forecast CRA resourcing. You also have experience utilizing a Functional Service Provider (FSP) monitoring model embedded within a sponsor study team to execute major data collection and study milestones. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites and CRAs.

What You’ll Do 

• Establish and foster effective relationships with internal and external stakeholders, such as the CRO and study team members.
• Promote awareness of Eikon’s clinical pipeline and programs to trial sites, investigators, and networks.
• Complete or oversee the qualification of sites and promptly facilitate site selection to support study milestone goals.
• Develop and maintain strong site relationships to support the site/patient experience and drive study team goals such as enrollment and major study milestones.
• Onboard and train CRAs to conduct high quality site qualification, initiation, and monitoring visits.
• Review and approve monitoring trip reports in the Clinical Trial Management System (CTMS).
• Perform and document monitoring oversight activities to assess monitoring quality and CRA performance.
• At times, perform the CRA role as needed, to support prompt site qualification, initiation, monitoring and close-out visits at key sites to meet urgent study milestones.
• Regularly review site and monitoring Key Risk Indicator (KRI) metrics to detect issues and ensure prompt resolution.
• Serve as an escalation point for CRAs and as a Subject Matter Expert (SME) to resolve site management and monitoring quality issues and develop/ensure implementation of Corrective and Preventive Action (CAPA) Plans as needed.
• Support CRAs to ensure sites are inspection-ready and support Eikon Clinical Quality Assurance during site inspections.
• Effectively utilize the CTMS and Trial Master File (TMF) to ensure SEME documents are promptly filed and site data is accurate.
• Contribute to monitoring process improvement initiatives by developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.
• Contribute to improving site selection, monitoring, and monitoring oversight trip report templates in Veeva CTMS by identifying gaps, suggesting updates, testing and implementing change controls.

Qualifications

• 8+ years of experience with a Bachelor's degree, or 6+ years with a post graduate degree
• Experience utilizing Veeva CTMS and TMF is required.
• Experience supporting site and/or sponsor inspections is required.
• Working on-site from an Eikon office location (Jersey City, NJ or Millbrae, CA) 3 days per week is required during non-travel weeks.​

The expected hourly range for this role is $77.40 to $84.50 depending on skills, competency, and the market demand for your expertise.

Position

We are currently seeking an experienced leader for the clinical operations role of Director Clinical Study Management & Operational Excellence within Clinical Study Management.  The Director will manage all aspects of clinical operations study management, for assigned Eikon clinical programs, and be responsible for exquisite inhouse execution of all interventional clinical trials and oversight of requisite clinical vendors. The role will also support the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical study management via a focus on operational excellence. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high quality, inspection ready studies is essential. The Director is responsible for trial quality and audit responses and completion of CAPAs. They will be a single point of contact for managing clinical trial operationally excellent execution in all its aspects across clinical study phases. The position has multiple stakeholder touch points within Clinical Research & Development (CR&D) staff and important interactions with, inter alia, Quality Assurance (QA), Finance, Regulatory, Clinical Supplies, Business Development and Legal in a matrix-based organization.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, New Jersey or Millbrae, California offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth and collaboration.

About You

You are agile of mind, systematic, and a collaborative leader with global oncology clinical development experience and a passion for operational excellence and advancing patient care. You possess a deep understanding of clinical trial regulations, guideline, and the principles of GCP, ensuring compliance throughout the clinical trial process.

What You’ll Do

• In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for operationally excellent delivery of assigned clinical protocols and programs.
• Manage clinical study management personnel across assigned clinical protocols and programs.
• Ensure that compliance, quality and timeline objectives are met for all assigned trials.
• Work collaboratively in a matrix organization with all internal stakeholders to deliver company clinical trial objectives on time, on budget and with high quality.
• Work with the CR&D Functional Area (FA) leads, as appropriate, in site management to accelerate enrollment and drive high quality.
• Take responsibility for any assigned clinical trial audits, working closely with the Clinical Quality Assurance group.
• Represent Clinical Study Management in operational excellence initiatives, in the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical trial management and execution. Key components of operational excellence, in clinical study management, are: (1) quality and compliance, (2) process optimization, (3) technology integration, (4) risk management, (5) performance metrics, (6) cross-functional collaboration.
• Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve CR&D objectives.
• Responsible for ensuring appropriate scientific and operational training for staff members.
• Serve as a talent magnet and develop, coach, and retain top talent in the clinical program team.
• Sets clear performance standards and holds self and organization accountable for achieving results with flawless execution.
• Embrace metrics and performance standards (KPIs) to drive continuous improvement in execution.

Qualifications

• A post-graduate degree with 12+ years of relevant experience with a Bachelor’s degree or 10+ years of relevant experience with a Master's Degree with a demonstrated working experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry. 
• Significant experience managing international clinical studies and programs in oncology.
• Proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
• Significant management experience in a clinical trial setting with the ability to service and collaborate with different CR&D stakeholders in a matrix organization.
• Demonstrated situational leadership, independence, problem solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment.
• Significant management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
• Strong communication skills requiring proficiency in written and spoken English.
• The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking and high emotional intelligence.
• Strong operational excellence mindset and experience.
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff.
• In addition, leadership skills that enable and drive alignment with the goals, purpose and mission of our company.

The expected hourly range for this role is $108.65 to $118.75 depending on skills, competency, and the market demand for your expertise.