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    Regional Clinical Study Manager - Oncology/ Solid Tumor

    Beigene
    4+ years
    $158K-$194K / yr. (est.)
    San Mateo
    10 March 3, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Regional Clinical Study Manager – Oncology/Solid Tumor (San Mateo, CA)

    Location: San Mateo, CA
    Salary Range: $158,000 - $194,000 per year (Estimated)
    Employment Type: Full-Time

    Position Summary:

    The Regional Clinical Study Manager will be responsible for delivering regional clinical studies with high-quality inspection readiness, within agreed timelines and budgets. This role will lead the regional clinical operations team, oversee external vendors, and act as the primary escalation point for study-related issues.

    Key Responsibilities:

    Regional Leadership:

    • Lead and manage the regional clinical operations team, ensuring effective decision-making and issue resolution.
    • Oversee external vendors involved in study delivery at the regional level.
    • Collaborate with key stakeholders and provide study progress updates to senior management and the Global Clinical Study Manager.
    • Represent the regional study team in internal meetings and cross-functional Clinical Study Team (CST) meetings.
    • Conduct regional operations meetings with all study team members.

    Timelines, Planning & Execution:

    • Lead planning and management of assigned clinical studies from feasibility to closeout for the region.
    • Track and maintain high-quality study start-up and recruitment timelines.
    • Ensure regional feasibility, country allocation, and site selection in collaboration with feasibility managers and stakeholders.
    • Provide regional input on global study plans.
    • Manage local adaptations of global study documents, ensuring timely submission to regulatory authorities and ethics committees.
    • Oversee regulatory submissions and approvals in collaboration with regional study start-up teams.
    • Ensure up-to-date and accurate study information in study systems and tools.
    • Collaborate with CRAs to ensure effective study execution at sites.
    • Manage Trial Master File (TMF) quality control and maintenance for the region.
    • Work with Global Clinical Supplies on drug inventory management and label reviews.
    • Oversee trial data collection, query resolution, and data entry compliance.
    • Support Clinical Study Report (CSR) planning and execution with Global Clinical Study Manager and Medical Writing teams.

    Quality & Compliance:

    • Resolve escalated study site issues and ensure compliance with protocols, SOPs, and ICH/GCP regulations.
    • Maintain inspection readiness throughout the study lifecycle.
    • Identify and address study-related risks, implementing mitigation strategies.
    • Prepare study sites for audits and inspections, ensuring prompt responses to findings.
    • Share cross-functional best practices and lead process improvements for efficiency and quality.

    Budget & Resource Management:

    • Select and manage regional study vendors in collaboration with the sourcing team.
    • Oversee regional study budgets, investigator fees, and site payments.
    • Address patient travel reimbursement and site financial issues with Clinical Business Operations.
    • Assess and allocate regional team resources, establishing contingency plans.

    Supervisory Responsibilities:

    • Provide performance feedback for team members.
    • Mentor junior clinical research professionals as needed.

    Required Qualifications:

    • Education: Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred.
    • Experience:
      • 4+ years in clinical research within biotech, pharma, or CRO industries.
      • Previous leadership experience in clinical operations.
      • Prior CRA experience is preferred.
    • Skills & Knowledge:
      • Strong understanding of clinical research processes, regulatory requirements, and ICH/GCP guidelines.
      • Proficiency in MS Office and project planning applications.
      • Experience in vendor selection, budgeting, and study management.
      • Excellent organizational, leadership, and communication skills.
    • Travel: May be required based on business needs.

    Apply now to join a dynamic clinical research team dedicated to advancing oncology and solid tumor therapies.

     

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