Senior Clinical Trial Manager
bluebird bio
Google Cloud Platform
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.
- Support or oversee the execution of select study/ies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.
- Accountable for planning and operational strategy and execution for assigned clinical trials; provide subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.
- During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; ensure accurate assumptions and robust risk management plans.
- Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.
- Support/review study budget planning and management and accountable for external spend related to study execution; work closely with COM (if applicable) and COPL, Global Program Management, and Finance.
- Communicate study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strategic Partner and/or other CROs.
- Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and supervision of performance for activities assigned to partners/vendors; escalate issues to governance committees when warranted.
- In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between strategy and tactical plan for database lock and CSR; support data review for database lock and CSR writing and review.
- Collect/review/file study documents in support of the trial master file (TMF) and regulatory filing.
- Responsible for overseeing study financial reconciliation and ensuring studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
- Site relationship management and review/oversight of trial audits; timely follow up to audit findings and CAPAs.
- Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparation.
Requirements
- Bachelor’s Degree or international equivalent required; Life Sciences preferred.
- 5+ years’ experience in pharmaceutical industry and/or clinical research organization
- 3+ years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA)
- Experience could 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
- 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 successful experience in project/program management and matrix leadership, e.g., timeline/budget management and risk identification and management
- Works independently and is highly organized
- Good communication skills
- Excellent teamwork, organizational, interpersonal, and problem-solving skills, including experience with leading cross-functional teams, vendor selection and oversight
- Experience managing recruitment challenges and boosting enrollment
- Fluent business English (oral and written)
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