Clinical Study Manager

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Role Summary

Clinical Study Manager, remote (Massachusetts – Virtual). Lead study operational strategy and planning and oversee execution of clinical studies for assigned clinical program(s), supporting the clinical strategy defined in the Clinical Development Plan. Report to the Clinical Operations Leadership team.

Responsibilities

• Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
• Oversee strategic partners and/or CROs and other 3rd party vendors to meet obligations described in ICH-GCP and Takeda’s business objectives.
• Accountable for planning and operational strategy and execution for assigned clinical trials.
• Provide subject matter expertise and operational input into protocol synopsis, final protocol and other study-related documents.
• Challenge study teams to ensure operational feasibility, including patient and site burden.
• Validate budget and ensure impacts are adequately addressed.
• Participate in country and site feasibility/selection process with a focus on ensuring alignment between study execution plan and program strategy.
• Ensure timelines meet the needs of the clinical development plan; onboard new team members and vendors as needed.
• Lead the development of the Operational Strategy during early engagement with Strategic Partner(s) and/or CROs; apply robust risk management plans.
• Provide oversight and guidance to Strategic Partners/CROs to address and resolve study issues rapidly.
• Manage study budgets and external spend; coordinate with Clinical Operations Program Leaders, Global Program Management, and Finance to keep budgets, enrollment, and gating accurate; communicate status and issues to leadership; escalate vendor issues.
• Oversee Strategic Partner/CRO/vendor selection, budget and contract negotiation, and supervision of performance; escalate issues to governance committees when warranted.
• Support sponsor oversight activities including monitoring plan approvals, study plan endorsements, meeting management, protocol deviation reviews, risk management, and collaboration with data management to align database timelines with the strategy and CSR; ensure studies are inspection-ready.

Qualifications

• BS/BA required, preferably in a health-related, life science area or technology-related fields, or equivalent combination of education, training and experience.
• Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience may supplement experience requirements.
• 5 or more years’ experience in the pharmaceutical industry and/or clinical research organization, including 3 or more years clinical study management/oversight and significant study management support experience.
• Experience in early phase studies or Phase 2/3 studies and global/international studies or programs; experience in more than one therapeutic area is advantageous.
• Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP; awareness of local country requirements.
• Demonstrated successful experience in project/program management and matrix leadership.
• Good communication skills.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).

Skills

• Excellent communication skills
• Strong teamwork, organizational, interpersonal, and problem-solving abilities
• Fluent business English (oral and written)
• Budget planning and management
• Vendor/Strategic Partner management
• Regulatory/compliance knowledge for clinical research
• Cross-functional collaboration
• Risk management

Education

• BS/BA required, preferably in a health-related, life science area or technology-related fields, or equivalent
• Advanced degree(s) (e.g., Master or Doctorate) may supplement