Lead Clinical Study Manager

Takeda

1d • Remote

About The Position

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? 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. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. 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. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: 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. 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. 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 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. 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 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

Requirements

• 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).

Nice To Haves

• 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.

Responsibilities

• 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.
• 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 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level