Job Details

Clinical Operations Manager

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. 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, enrolment, 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; 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 Clinical Operations Manager role in functional initiatives or working groups. Help with onboarding and mentoring of new or junior COMs. May assist the program COPL in his/her role, as required.

Education: Bachelors Degree or international equivalent required; Life Sciences preferred. Knowledge & Skills: 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.