Clinical Study Manager

Role Summary

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

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 other CROs and other 3rd party vendors to meet Takeda‚Äôs obligations described in ICH-GCP and Takeda‚Äôs 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 team to ensure operational feasibility, inclusive of patient and site burden.
• Validate budget and ensure impacts are adequately addressed.
• Participate in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.
• Challenge study team to ensure timelines meet the needs of the clinical development plan.
• Ensure new team members and vendors are appropriately onboarded.
• Lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.
• Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.
• Responsible for study budget planning and management and accountable for external spend related to study execution. Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.
• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies.
• Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring.
• Review and endorsement of relevant study plans, as applicable.
• Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes.
• Review of outcomes/actions related to protocol deviations review; identify trends across sites and/or the study.
• Documented review and monitoring of issues, risks and decisions at the study level and implementation of mitigation strategies.
• In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between strategy and tactical plan for database lock and CSR.
• Ensure studies are ‚Äúinspection ready‚Äù; may be involved in regulatory inspections by preparing for and/or attending the inspections.

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 requirements.
• 5+ years‚Äô experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management/oversight.
• Experience in early phase or Phase 2/3 global/international studies; multiple therapeutic areas advantageous.
• Knowledge of global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP); awareness of local country requirements.
• Demonstrated project/program management and matrix leadership experience.
• Good communication, teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).

Skills

• Operational strategy and planning
• Budgeting and financial management for clinical studies
• Vendor and CRO management
• Protocol development and study documentation
• Feasibility assessment and site/country selection
• Risk management and issue resolution
• Cross-functional collaboration

Education

• BS/BA in a health-related or life sciences field; advanced degree preferred