Lead Clinical Study Manager

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. 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. The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. 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 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. focus on ensuring accurate assumptions are applied and robust risk management plans are in place. 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 Study team meeting management and attendance when necessary; 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; filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. 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. BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.

• Master or Doctorate) and relevant training or experience (e.g., 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.
• Fluent business English (oral and written).

TRAVEL REQUIREMENTS:

~ Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. Massachusetts - Virtual U.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Massachusetts - Virtual Worker Type Full time Job Exempt