Position Title: Associate Clinical Operations Program Leader II
Contract length: 6 months
Function: Translational Research & Early Clinical (TREC) or Global Development Operations Department: Early or Late Development Operations
OBJECTIVES of Associate Clinical Operations Program Leader II:
- 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.
- Responsible for oversight of 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.
- Oversight of 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 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 of Associate Clinical Operations Program Leader II :
- Accountable for planning and operational strategy for assigned clinical trials
- Provides subject matter expertise and operational input into protocol synopsis and final protocol document
- 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 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
- With Strategic Partner(s) and/or other CROs, support 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 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 Leader(s) ; serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
- Oversight of 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 risk based monitoring documents/plans, periodic review of outputs, decisions and actions related to risk based monitoring
- Review and endorsement of Data Management Strategy and Operational Plan, a document which focuses on data concepts and data management principles at the study level
- Study team (SET/CTWG) meeting 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 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.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS of Associate Clinical Operations Program Leader II:
Education: Bachelor's Degree or international equivalent required, Life Sciences preferred. Skills:
- Expertise 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 teamwork, organizational, interpersonal, and problem-solving skills
- Fluent business English (oral and written)
Experience: 5+ years' experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management strongly preferred. Experience must include 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.
Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. Must work on site at least 3 days a week
Sthree US is acting as an Employment Business in relation to this vacancy.