About QuantHealth

QuantHealth is a growing AI startup in the clinical trial space, leveraging AI, biomedical data, knowledge graphs, and real-world patient data to simulate and optimize clinical trials for pharmaceutical companies. Our platform combines large-scale biomedical knowledge, clinical trial data, and patient-level data to help customers simulate clinical trials, reduce development risk and cost, shorten timelines, and improve the probability of clinical trial success.

About the Role

This role combines day-to-day IT help desk support with ownership of identity and access
governance across the organization. The successful candidate will serve as the primary
point of contact for end-user IT issues while also acting as the gatekeeper for user
provisioning, access control, and compliance with IAM policies.

Responsibilities - IT HELPDESK

· Serve as the first point of contact for IT support requests via ticket, phone, or in
person
· Troubleshoot hardware, software, network, and connectivity issues for end users
· Perform password resets, account unlocks, and MFA resets
· Escalate unresolved issues to second-line support or specialist teams
· Maintain and update the IT helpdesk knowledge base and ticket records
· Set up and configure workstations, laptops, and peripherals for new joiners

Responsibilities - IDENTITY & ACCESS GOVERNANCE

· Create, modify, and deactivate user accounts across Active Directory, Office 365,
and other enterprise platforms
· Manage user provisioning and deprovisioning throughout the employee lifecycle
(onboarding, role changes, offboarding)
· Enforce role-based access control (RBAC) and least-privilege principles across
systems and applications
· Process and review access requests, ensuring approvals align with security policies
· Conduct periodic access reviews and recertification campaigns to identify and
remediate role drift
· Monitor and audit access logs to detect anomalies or policy violations
· Support segregation of duties (SoD) policy enforcement
· Maintain documentation for IAM processes and contribute to policy updates
· Assist with compliance requirements (e.g. ISO 27001, GDPR, SOX) as they relate to
access governance

Qualifications

· 1-3 years in an IT helpdesk or IT support role
· Hands-on experience with Office 365/ Google workspace administration
· Working knowledge of IAM concepts: SSO, MFA, RBAC, LDAP, SAML
· Familiarity with ticketing systems (e.g. Jira Service Management)
· Strong troubleshooting and analytical skills
· Clear communication skills, able to explain technical issues to non-technical users
· High attention to detail and commitment to data accuracy

Nice to have

· Exposure to IGA (Identity Governance & Administration) tools
· Scripting skills in PowerShell or Python for automation tasks

• Own full-cycle bookkeeping activities through the trial balance stage
• Manage the end-to-end monthly payroll process for Israel-based employees
• Ensure full compliance with Israeli tax regulations, including VAT, income tax, and withholding tax
• Prepare and submit statutory payroll reports, including Forms 102 and 126
• Maintain accurate, well-organized financial records and supporting documentation
• Support month-end and year-end closing processes
• Assist with audit preparation and coordinate with external auditors.
• Work with financial systems, including NetSuite, Michpal, and related tools
• Proactively identify and implement process improvements to enhance efficiency across finance operations

• AI Proficiency & Tech-Forward Mindset: Ability to leverage AI tools to optimize financial workflows, automate data analysis, and improve the speed and accuracy of reporting.
• 2–3+ years of experience in bookkeeping and payroll
• Certified Bookkeeper (Type 2 or 3) and Certified Payroll Clerk
• Proven experience with full-cycle bookkeeping through trial balance and month-end close
• Strong knowledge of Israeli payroll, labor laws, and tax reporting requirements
• Hands-on experience with NetSuite, Michpal, and Excel (or similar systems)
• Experience in a high-tech company or CPA firm — an advantage
• Fluent in Hebrew and high-level English (written and spoken)
• Strong attention to detail and ability to handle sensitive and confidential information
• Ability to work independently, prioritize effectively, and meet deadlines

About QuantHealth

QuantHealth is a growing AI startup in the clinical trial space, leveraging AI, biomedical data, knowledge graphs, and real-world patient data to simulate and optimize clinical trials for pharmaceutical companies. Our platform combines large-scale biomedical knowledge, clinical trial data, and patient-level data to help customers simulate clinical trials, reduce development risk and cost, shorten timelines, and improve the probability of clinical trial success.

About the Role

As a Data Scientist in the CDS R&D team, you will play a key role in researching, developing, and productionizing advanced data science solutions that power QuantHealth’s clinical simulation and prediction capabilities.

This role is designed for a strong applied data scientist who enjoys solving complex, ambiguous problems end-to-end: from data exploration and feature engineering, through model development and validation, to building scalable pipelines and AI-driven workflows. You will work closely with clinical experts, product, delivery, engineering, and other data science teams to translate challenging clinical and biomedical questions into robust data-driven solutions.

The ideal candidate brings several years of hands-on experience in applied data science, machine learning, and data pipeline development. Additional qualities we look at in candidates are scientific thinking, project ownership, and the ability to independently learn and operate in complex domains. Experience with biomedical or clinical data is a strong advantage.

This position involves working with a modern Python-based data science stack, building predictive models, developing data and ML pipelines, and contributing to the continuous improvement of QuantHealth’s clinical trial simulation product. The role requires curiosity, strong self-learning abilities, research orientation, and rigorous analytical thinking.

Responsibilities

• Design, develop, and validate data science models, algorithms, and tools that support QuantHealth’s internal and customer-facing clinical simulation products.
• Build end-to-end data science solutions, including data ingestion, feature engineering, model development, evaluation, and deployment-ready pipelines.
• Collaborate with clinical, product, delivery, engineering, and data science teams to prototype and implement data-driven solutions.
• Explore, process, and integrate diverse data sources, including clinical trial data, EHR/RWD, biomedical literature, biomedical ontologies, and knowledge graphs.
• Develop scalable ETL and data pipelines to support automated clinical simulation workflows.
• Build LLM-based and agentic systems to automate internal research, data processing, and biomedical reasoning workflows.
• Develop and improve data projects using tools such as PySpark, PyTorch, PyGeometric, MLflow, SQL, and the broader Python data stack.
• Stay current with emerging methodologies in machine learning, LLMs, knowledge graphs, biomedical AI, and applied data science.
• Contribute to internal knowledge sharing, best practices, and scientific discussions within the R&D organization.

Qualifications

• MSc or PhD in data science, computer science, computational biology, or a related quantitative field.
• 4+ years of hands-on experience in applied data science, machine learning, or algorithm development.
• Strong Python skills and practical experience with common data science and ML libraries such as pandas, NumPy, scikit-learn, PyTorch, SQL, and Spark.
• Proven experience building end-to-end data science solutions, from raw data processing to model development, evaluation, and implementation.
• Experience working with large, messy, real-world datasets and transforming them into reliable analytical or machine learning pipelines.
• Strong understanding of machine learning concepts, model evaluation, statistical analysis, and experimental design.
• Experience with cloud-based computing environments and scalable data processing pipelines.
• Strong analytical and problem-solving skills, with attention to details and scientific rigor.
• Strong research mindset and ability to independently learn new domains, methods, and technologies.
• Excellent communication skills and ability to collaborate effectively across clinical, product, engineering, and data science teams.

Strong Advantages

• Experience working with biomedical, healthcare (RWD/EHR), pharmaceutical, biomedical ontologies, or real-world patient data.
• Experience developing LLM-based workflows or agentic pipelines.
• Experience with knowledge graphs, graph embeddings, GNNs, or graph-based ML.
• Experience with PySpark, PyTorch, PyGeometric, MLflow, or similar ML engineering tools.
• Experience creating interactive data applications, dashboards, or internal tools.
• Familiarity with clinical trial design, drug development, computational/system biology, or translational medicine.

About QuantHealth

QuantHealth is a growing AI startup in the clinical trial space, leveraging AI, biomedical data, knowledge graphs, and real-world patient data to simulate and optimize clinical trials for pharmaceutical companies.

Our platform helps customers simulate clinical trials, reduce development risk and cost, shorten timelines, and improve the probability of clinical trial success.

About the Role

We are looking for a Senior Data Scientist to lead the development of QuantHealth’s internal platform for streamlining, automating, and standardizing key customer delivery workflows.

This is a hybrid role at the intersection of data science, software engineering, ML systems, and internal product development. The ideal candidate is a strong builder who can take ownership of complex workflows, understand complex real-world data and modeling processes, and turn them into reliable, reusable, scalable systems.

The internal platform will serve as a central layer for improving how customer delivery work is planned, executed, automated, and reused across projects. It will bring together key workflows, automatic agentic systems, data assets, computational processes, reusable components, and quality-control mechanisms into a more integrated and scalable operating model. The goal is to reduce manual effort, improve consistency, shorten delivery timelines, increase transparency, and create reusable institutional knowledge across projects. This role requires someone who is comfortable moving between data science, architecture, software development, data pipelines, AI-driven automation, and internal applications. It also requires collaboration with delivery, clinical, engineering, and data science teams. It is a senior individual contributor role with high ownership and broad impact.

Responsibilities

• Lead the design and development of a set of internal tools that streamline, automate, and scale the company's delivery workflows and model development lifecycle.
• Build data-science-driven systems that combine data pipelines, AI-driven automation, analytical workflows, and internal applications.
• Develop LLM-based and agentic workflows to automate complex operational and analytical processes.
• Implement validation, monitoring, and quality control mechanisms to improve reliability, reproducibility, and trust in delivery outputs.
• Design solutions that support versioning, traceability, access control, and reuse of data and analytical assets.
• Collaborate closely with delivery, clinical, data science, product, and engineering teams to translate operational challenges into scalable technical solutions.
• Own key technical design decisions and contribute to the long-term direction of the internal delivery platform.
• Improve the reliability and maintainability of existing internal tools, workflows, and automation processes.
• Create clear documentation, standards, and best practices for using and extending the system.
• Act as a senior technical contributor, providing guidance and mentorship to junior team members on data science workflows, automation design, code quality, and systems-building best practices.
  
  

Qualifications

• MSc or PhD in computer science, data science, computational biology, or a related quantitative/technical field.
• 6+ years of hands-on experience in applied data science, machine learning, data engineering, or a hybrid data science / systems-building role.
• Strong experience developing complex data science solutions, including data pipelines, automation workflows, model evaluation, and production-oriented implementation.
• Strong Python skills, with the ability to write clean, modular, reliable code for data science and automation workflows.
• Experience working with large, complex, real-world datasets and turning them into reliable data products, pipelines, or analytical workflows.
• Experience integrating data, models, APIs, or internal tools into practical end-to-end solutions.
• Experience with cloud environments, containerization, CI/CD, and production deployment workflows.
• Experience building user-facing automation tools or internal applications that collect user input, guide workflows, and translate user needs into reliable automated processes.
• Strong understanding of machine learning concepts, model evaluation, analytical validation, and experimental design.
• Ability to work with ambiguous requirements, break down complex operational and analytical workflows, and translate them into practical technical solutions.
• Strong product sense for internal tools: ability to understand users, simplify workflows, and build solutions that people actually use.
• Strong analytical and problem-solving skills, with attention to detail, reliability, and reproducibility.
• Excellent communication skills and ability to collaborate across data science, engineering, clinical, product, and delivery teams.
  
  

Strong Advantages

• Experience leading the development of internal platforms, workflow automation systems, data products, or operational tools for technical teams.
• Experience building LLM-based and agentic applications, retrieval systems, or automated reasoning workflows.
• Experience with access control, identity management, audit logs, data lineage, or regulated-data environments.
• Experience working with healthcare, clinical, biomedical, pharma, or real-world patient data.
• Experience working in a startup environment where ownership, speed, and pragmatic engineering are critical

QuantHealth is an AI startup revolutionizing drug development and clinical trials. Our cutting-edge clinical trial simulator can run thousands of trials in parallel to de-risk and optimize real-world clinical trials. Powered by a unique dataset of over 350M patients and 100K drugs, our platform helps drastically reduce drug development costs and timelines. We’re venture-backed, based in Israel, and work with top-tier pharma companies across Europe and the US. 

We are looking for a Senior Back End Engineer (API & Agentic AI) to play a key role in the evolution of QuantHealth’s backend architecture and emerging AI platform capabilities. This role will contribute significantly to the transition from a monolithic application to a multi-service backend platform, while also helping design and implement the backend foundations for agentic AI systems used across our product.

You will work on core backend services, API design, and distributed system concerns, and collaborate closely with full stack, product, data science, and security teams to build scalable, secure, and well-observed services that support both human-facing workflows and autonomous AI agents.

What You’ll Do

Backend & Platform Architecture

• Contribute to the design and implementation of a multi-service backend architecture

• Design, build, and maintain robust, well-documented APIs for internal and external consumers

• Help define backend standards that support both traditional SaaS workflows and AI-driven, agent-based execution

• Collaborate on architectural decisions and provide technical guidance within the engineering team

Agentic AI Enablement

• Design backend primitives and services that support agentic AI systems (e.g., task execution, state management, orchestration, tool invocation)

• Build APIs and infrastructure that allow AI agents to safely interact with internal services, data, and external systems

• Implement guardrails for agent execution, including authorization boundaries, auditability, rate limits, and failure handling

• Partner with data science and ML engineers to productionize AI workflows in a reliable, observable, and secure way

Backend Best Practices & Reliability

• Implement and improve backend best practices, including:

  • Authentication and authorization (token-based auth, RBAC, service-to-service auth)

  • Idempotency and safe retry mechanisms

  • Consistent error modeling and API contracts

  • Input validation and schema enforcement

  • API versioning and backward compatibility

• Ensure backend services follow strong networking and security principles

• Help establish and maintain observability standards (logging, metrics, tracing)

• Write high-quality, well-tested TypeScript code

What We’re Looking For

• 7+ years of professional software engineering experience, primarily focused on backend systems

• Strong expertise in TypeScript for server-side development

• Proven experience designing and implementing APIs for complex systems

• Experience with Nest.js or another major TypeScript backend framework (e.g., AdonisJS, Express, Fastify, Koa)

• Solid understanding of:

  • HTTP and networking fundamentals

  • API security and authentication/authorization patterns

  • Reliability concerns in distributed systems

• Experience with:

  • API documentation (OpenAPI / Swagger)

  • Testing strategies (unit, integration, API tests)

  • Validation and contract-driven development

• A pragmatic, ownership-oriented mindset with strong engineering judgment

• Comfort working in systems that mix deterministic software with probabilistic AI components

Nice to Have

• Experience participating in monolith-to-services or modularization efforts

• Experience supporting external, customer-facing APIs

• Experience designing systems that support AI agents, workflows, or automation platforms

• Familiarity with LLM tooling concepts (tools/functions, agent loops, structured outputs)

• Experience with Effect

• Familiarity with healthcare, life sciences, or regulated environments

• Experience with cloud-native deployments and production observability tooling

Why QuantHealth

• Work on technically deep problems at the intersection of backend systems and AI in healthcare

• Help shape both a scalable backend platform and the foundations of agentic AI capabilities

• Collaborate with a thoughtful, high-caliber engineering team

• Competitive compensation and opportunities for growth

QuantHealth is an AI startup revolutionizing drug development and clinical trials. Our cutting-edge clinical trial simulator can run thousands of trials in parallel to de-risk and optimize real-world clinical trials.
Powered by a unique dataset of over 350M patients and 100K drugs, our platform helps drastically reduce drug development costs and timelines. 
We’re venture-backed, based in Israel, and work with top-tier pharma companies across Europe and the US. 


Role Overview
We are seeking a highly analytical, hands-on FP&A professional to build and lead the financial planning and business analytics function from the ground up. Reporting to the CFO, this role will partner closely with Finance, RevOps, and business leaders to drive budgeting, forecasting, KPI development, and strategic analysis. 
You will be deeply involved in planning, budgeting, business performance analysis, and KPI measurement, while also working closely with the accounting team during month-end to ensure accurate, insightful reporting. This role will support board and executive reporting, translating complex financial and operational data into clear, actionable insights. This is an ideal role for someone who thrives in a high-growth environment, enjoys building structure and process, is able to partner with technical and commercial leaders and wants significant visibility and impact.

What you'll do

Financial Planning & Forecasting

• Own the company’s budgeting, forecasting, and long-range planning processes
• Develop scalable financial models to support growth, scenario planning, and strategic initiatives
• Partner with functional leaders to understand business drivers and incorporate them into financial plans
• Continuously improve forecasting accuracy and planning processes as the company scales

Business Analysis & KPI Management

• Design, define, and maintain core financial and operational KPIs across SaaS and services lines
• Perform deep-dive analyses on revenue, COGS, margins, customer economics, headcount, and operating expenses
• Identify trends, risks, and opportunities, and proactively communicate insights to leadership
• Build dashboards and reporting packages that are intuitive, visually clear, and decision-oriented

Month-End & Accounting Partnership

• Work closely with the accounting team during month-end close to provide analysis, Revenue and COGS support, and variance explanations
• Bridge the gap between accounting results and business performance, ensuring leadership understands the “why” behind the numbers
• Help ensure consistency between financial reporting, forecasts, and KPIs

Executive & Board Reporting

• Prepare executive-level and board-level reporting with clear narratives and data-backed insights
• Translate complex financial data into concise, well-presented materials that drive understanding and action
• Support ad-hoc analyses for leadership, investors, and strategic decision-making

Function Build-Out

• Establish FP&A processes, tools, and adoption of best practices 
• Partner with Finance leadership on system selection, data structure, and reporting infrastructure
• Help define what “great FP&A” looks like as the company continues to grow

What We’re Looking For

• 7-10+ years of experience in FP&A ideally within SaaS and technology environments
• Proven ability to operate independently as an individual contributor while building scalable FP&A processes from the ground up
• Strong experience with budgeting, forecasting, financial modeling, and business analysis
• Hands-on experience partnering with accounting teams and supporting month-end close
• Ability to synthesize data into clear, compelling insights for executives and boards
• Advanced Excel skills plus experience with BI tools and financial systems 
• Comfortable operating in ambiguity 
• Strong communication skills with the ability to influence cross-functional stakeholders

What Success Looks Like

• Leadership has clear, timely visibility into company performance and key drivers
• Budgeting and forecasting are reliable, scalable, and tied directly to business strategy
• Board and executive materials are crisp, insightful, and easy to understand
• FP&A becomes a trusted strategic partner across the organization

About Us

PhaseV (HQ in Boston, R&D in Tel Aviv) is a cutting-edge startup, pushing innovation in the drug development process to bring new treatments to more patients, in a more efficient and precise way. Leveraging the power of advanced causal inference and pushing the boundaries of machine learning, PhaseV detects hidden signals in clinical data and extracts actionable insights for planning the optimal trial. The company's proprietary ML-based platform for adaptive clinical trial design and closed-loop execution enables sponsors to easily and quickly unlock the potential of adaptive clinical trials, reveal the optimal adaptive design to meet their trial objectives and execute more efficient, more precise, and more successful clinical trials. Collaborating with 7 of the top pharmaceutical companies, as well as multiple CROs and biotech, we are poised to make a significant impact on how drugs are developed and brought to market.

About the Role

We are looking for a hands-on, experienced QA Engineer  to join our team and take ownership of the company’s engineering testing. This is a critical role for someone who thrives in a fast-paced startup environment and is eager to help scale our Engineering infrastructure while ensuring our product excellence.
As a System QA, you will be responsible for E2E testing features of our fast-evolving product, by building a complex  environment and simulating customers' requirements. You will be the only gatekeeper for various new features and enhancements before they are deployed .

Responsibilities

• Hands-on experience and in-depth knowledge of  manual and automation testing
• At least 4 years of Automation (Python) experience in complex, multi-layered SW systems
• Programming experience - scripting and/or OOPA team player with excellent collaboration skills Ability to multi-task and work in a fast-paced environment.
• Experience with SaaS products CCNP/JNCIP certified
• Experience with traffic generators (Trex, breaking-point, Avalanche, Test center)BSc. degree in Computer Science - Advantage
• Work closely with multiple R&D teams across PhaseV
• Enable development teams to own testing and automation as an integral part of delivery
• Design scalable quality strategies, testing frameworks, and quality gates to ensure high standards without slowing down development
• Act as a technical authority as you guide teams on testability, observability, and risk-based testing, as well as non-functional quality aspects such as security, performance, and reliability.
• Partner with Engineering, Product, and DevOps to continuously improve how quality is designed, measured, and enforced across the product lifecycle.
  
  Requirements
  
  At least 4 years of experience in quality testing complex systems Practical hands-on knowledge of cloud technologies (AWS), Kubernetes, Docker
• Hands-on experience with automation frameworks such as Playwright with Python
• Experience with leveraging Generative AI tools to accelerate quality-related tasks: test case creation, bug reporting, scripting/tooling, and more – an advantage
• Ability to guide development teams, provide clear and constructive quality feedback, and challenge design or implementation decisions
• Ability to take ownership using strong problem-solving and decision-making skills
  
  

The Position

We're seeking a talented, experienced Product Manager to join our Tel Aviv team. In this role, you'll tackle the thrilling challenge of building an intuitive, efficient platform that redefines how clinical trials are designed and conducted, leveraging AI and innovation to transform drug development. You'll collaborate closely with our engineering, data science, algorithm research, and clinical teams to create and refine a state‑of‑the‑art trials platform. This is a rare opportunity to make a tangible impact on how new therapies reach patients and to revolutionize healthcare delivery.

Key Responsibilities

• Bridge end‑user needs and AI‑powered capabilities to design and deliver transformative products
• Play a critical role in defining the product vision and roadmap
• Work closely with engineering and algorithm developers to fulfill product goals
• Turn strategic goals into focused, compelling product plans
• Create structure, focus, and momentum within fast-moving environments
• Actively engage with customers and internal stakeholders throughout the product development lifecycle

Required Qualifications

• 4+ years of product management experience (Preferably on a B2B product)
• Proactive learner who rapidly builds deep domain expertise 
• Thrive in fast‑paced settings, seamlessly switching contexts across multiple initiatives
• Ownership mindset that drives accountability and empowers cross‑functional teams
• Hands-on experience collaborating with engineering and data-science teams on product development
• Familiarity with AI tools, workflows, and opportunities
• Comfortable with statistics, able to engage meaningfully with data‑science counterparts (advantage)

About Us

PhaseV (HQ in Boston, R&D in Tel Aviv) is a fast-moving startup redefining clinical trial design with a cloud-native, AI-first platform. Founded in 2023, we combine causal machine learning, adaptive trial design, and real-world data to deliver smarter, faster, and more efficient drug development. 

Backed by a $50 million Series A, we’re enabling sponsors, biotechs, and CROs to uncover hidden insights, optimize trial scenarios in real time, and accelerate the path from molecule to medicine. 

At PhaseV, every innovation has one destination: speeding critical treatments from lab to patient.

About Us

PhaseV (HQ in Boston, R&D in Tel Aviv) is a cutting-edge startup, pushing innovation in the drug development process to bring new treatments to more patients, in a more efficient and precise way. Leveraging the power of advanced causal inference and pushing the boundaries of machine learning, PhaseV detects hidden signals in clinical data and extracts actionable insights for planning the optimal trial. The company's proprietary ML-based platform for adaptive clinical trial design and closed-loop execution enables sponsors to easily and quickly unlock the potential of adaptive clinical trials, reveal the optimal adaptive design to meet their trial objectives and execute more efficient, more precise, and more successful clinical trials. Collaborating with 7 of the top pharmaceutical companies, as well as multiple CROs and biotechs, we are poised to make a significant impact on how drugs are developed and brought to market.

The Position

We are looking for a talented and driven backend developer to join our Tel Aviv team. In this role, you will work closely with our data science, algorithm research, and clinical teams to create and refine a state-of-the-art clinical trials platform. You’ll take on the exciting challenge of developing an intuitive, efficient, and scalable solution that transforms how drug development clinical trials are designed and executed. This is a unique opportunity to make a tangible impact on cutting-edge healthcare innovation while working at the intersection of technology, data, and medicine.

Duties and Responsibilities

• Develop a complex, cloud-based solution, and maintain its high level of quality
• Demonstrate a proactive, solution-driven mindset to deliver results.
• Help in designing robust, scalable, and testable software solutions in a fast-paced environment
• Take an active part in all development phases, including research, design, development, testing

Required Qualifications

• BSc in Computer Science from a recognized university or equivalent practical experience
• Substantial experience in server-side development
• Minimum 5 years of experience in Python development
• Over 5 years of experience in designing and developing APIs
• At least 3 years of hands-on experience with both relational and NoSQL databases, demonstrating strong database design skills.
• 3+ years of experience with AWS, showing proficiency in leveraging AWS services for building and maintaining scalable cloud applications.
• 3+ years of experience in using Docker and Kubernetes, with a solid track record of deploying and managing containerized applications in production environments.
• Last but not least, passion for working on a meaningful product with strong independent coworkers.

What We Offer

A chance to be a part of a groundbreaking team in the clinical trial domain.

An innovative and collaborative work environment.

Opportunities for personal and professional growth

Your role:

• Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution
• Provide project updates to project management team.
• Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.
• Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.
• Assists with, prepare for, and attends Investigator Meetings for assigned studies.
• Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.
• Collect and review essential study documents from site for filing in eTMF.
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
• Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, performing review and oversight of site visit reports.
• May review protocols, eCRFs, study manuals and other study related documents, as requested by the Clinical Trial Manager.
• May conduct on-site evaluation visits and on-site training of CRAs
• Lead and partake in regular team meeting / teleconferences.
• Assist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.
• May serve as mentor to associates on the subject of job performance, trainings and professional growth.
• Other duties as assigned. 

Your Profile:

• Bachelor’s Degree in biomedical sciences or related scientific discipline
• Fluent English (oral and written) and applicable local business language.
• Minimum three years of monitoring experience, more experience preferred, with a combination of clinical research coordinator and or other relevant clinical research experience.
• Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process.
• Ability to travel up to 70%, depending on project requirements.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• Good leadership, planning, project management skills, verbal communication skills, and written communication skills.
• Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint and Excel).

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.