Lead Clinical Study Manager

Role Summary

Lead Clinical Study Manager role based remotely, reporting to the Clinical Operations Leadership team. Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in the Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s). Location: Massachusetts - Virtual.

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 gating 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

Qualifications

• Required: 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. Experience in more than one therapeutic area is advantageous.
• Required: 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.
• Required: Demonstrated excellence in project/program management and matrix leadership.
• Required: Excellent communication skills.
• Required: Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Required: Fluent business English (oral and written).

Education

• 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 (e.g., fellowship, internships, etc.) may be considered to supplement experience requirements.

Additional Requirements

• Travel Requirements: Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.