Clinical Trial Manager (or Senior Manager)

Clinical Trial Manager (or Senior Manager)

Position Summary:
Reporting to the VP of Clinical Operations, provide senior-level leadership for planning, execution, oversight, and delivery of clinical studies across Phase I/Ib/II/III programs. Independently lead complex regional and global trials; drive operational strategy; manage study budgets and timelines; oversee CROs/vendors; ensure inspection readiness and compliance with GCP, ICH, protocol, and regulatory requirements.

Job Duties:
- Independently lead/manage Phase I/Ib/II/III clinical studies (moderate to high complexity), including large regional/global trials.
- Provide clinical operations leadership across the study lifecycle (start-up, enrollment, maintenance, closeout, inspection readiness).
- Execute study operational plans: timelines, budgets, risk mitigation, communication, monitoring, and vendor oversight.
- Serve as primary operational lead for assigned studies; lead workstreams as needed.
- Lead cross-functional teams; align internal stakeholders, CROs, vendors, and clinical sites.
- Provide primary CRO/vendor oversight: performance management, issue escalation, deliverable review; accountable for quality, budget, timelines.
- Contribute to clinical plans, budgets, timelines, feasibility assessments.
- Identify/escalate risks and implement contingency/mitigation strategies.
- Oversee clinical systems (EDC, CTMS, eTMF, IWRS, lab portals) for data integrity, QC, and accurate reporting.
- Maintain TMF quality/completeness/inspection readiness.
- Provide regular study updates, milestones, dashboards, and metrics.
- Support data review, cleaning, query resolution, and database lock.
- Support sites via monitoring/site management as required.
- Manage study correspondence, documentation, and files for audit readiness.
- May mentor junior staff/contractors.

Required Education & Experience:
- BA/BS in Health/Life Sciences or related field (advanced degree preferred).
- 7+ years clinical operations or clinical trial management (or equivalent).
- 5+ years clinical R&D with proven independent trial management.
- Experience leading/substantially overseeing Phase I/Ib/II/III trials (complex, global/regional/multi-site).
- Experience managing CROs/vendors, budgets, timelines, and deliverables.

Required Qualifications/Skills:
- Strong leadership/influencing, interpersonal, and written/verbal communication.
- Advanced project management and organization; highly reliable, solutions-oriented.
- Advanced Microsoft Office/Project/Excel and clinical tracking/reporting tools.
- In-depth GCP/ICH/regulatory and inspection readiness knowledge.
- Ability to manage multiple complex studies and competing priorities.
- Deep clinical systems knowledge (EDC/CTMS/eTMF/IWRS/lab portals).
- Advanced TMF management (quality control, completeness, inspection readiness).
- Hands-on experience overseeing eTMF, CTMS, EDC, study plans/trackers/reports.
- Experience maintaining audit/inspection readiness with vendors.
- Experience in small/early-stage biotech (hands-on, resource-conscious).
- Experience with global/regional/multi-site trials.
- Demonstrated CRO/vendor oversight (performance, escalation, deliverable accountability).