Note: The job is a remote job and is open to candidates in USA. Takeda is a patient-focused, innovation-driven pharmaceutical company committed to transforming healthcare through R&D-driven leadership and life-changing work. The Lead Clinical Study Manager will lead operational strategy, planning, oversight, and execution for complex clinical studies, managing study quality, timelines, budgets, vendors, and regulatory readiness.
Responsibilities
- 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)
- 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’s obligations described in ICH-GCP and Takeda’s business objectives
- 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 team 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 team 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 issues are addressed and resolved rapidly
- Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; 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, including escalation of issues to governance committees when warranted
- 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; primary purpose of review is to support the identification of trends across sites and/or the study
- Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies
- In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR
- Ensure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections
- Represent the Lead Clinical Study Manager role in functional initiatives or working groups
- Help with onboarding and mentoring of new or junior CSMs
- May assist the program COPL in his/her role, as required
Skills
- BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience
- 6+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs
- Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required
- Demonstrated excellence in project/program management and matrix leadership
- Excellent communication skills
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Fluent business English (oral and written)
- Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel
- Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements
- Experience in more than one therapeutic area is advantageous
Benefits
- This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy
- U.S. based employees may be eligible for short-term and/ or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company Overview
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