Lead Clinical Study Manager

Job Title:

Lead Clinical Study Manager (Lead CSM)

BU/Organization:
Global Development Organization (GDO)

Department/Function:
Global Clinical Development Operations (GCDO) / Study Management

Location and Flex Work Arrangement:
Remote

Job Code/Job Profile: not required for contractor

Supervisor:
Associate Director/Director, Study Management

Compensation Grade Profile: not required for contractor 150

Objective /

Purpose:

Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.

In close collaboration with Clinical Operations Program Lead(s):

• Lead the cross functional study execution team (SET) for assigned clinical studies program(s) to meet study objectives 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’s obligations described in ICH-GCP and Takeda’s business objectives.
• May collaborate with one, or more, CSMs, or other study management colleagues
• The assigned clinical studies may be of high-level of complexity and/or high priority. More than one study and/or more than one program may be assigned

Accountabilities:

• Accountable for planning and operational strategy and execution for assigned clinical trials.
• Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.
• Challenges study execution team (SET) to ensure operational feasibility, inclusive of patient and site burden
• Validates budget and ensures impacts are adequately addressed.
• Participates 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.
• Challenges study execution team (SET) to ensure timelines meet the needs of the clinical development plan.
• Ensure new team members and vendors are appropriately onboarded.
• During Early Engagement with Strategic Partner(s) and/or other CROs, 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 risks are identified and mitigated, and issues are addressed and resolved rapidly.
• Responsible for study budget planning and management and accountable for external spend related to end-to-end study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, external spend, enrollment, and ensure timely updates of budget and financial systems are accurate. Communicates study status, cost and issues to Clinical Operations Program Lead(s);
  
  serve as escalation point for third party vendors managed by Takeda and/or Strategic Partner and/or other CROs.
• Communicates study status, cost and issues to Clinical Operations Program Lead(s); serves as escalation point for third party vendors managed by Takeda, 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, including escalation of issues to governance committees when warranted.
• Specific areas of sponsor oversight include, but are not limited to:
  • Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to…