Senior Clinical Trial Manager
Enigma Search
Senior Clinical Trial Manager
South San Francisco, California, United States
Role Summary
Hands-on clinical trial leader responsible for day-to-day execution of mid to late-stage CKD studies. This role partners closely with cross-functional teams and external vendors to ensure studies are delivered on time, within budget, and with high data quality and compliance standards.
Core Responsibilities
Study Execution
- Co-lead Phase 2-3 CKD study execution from protocol development through CSR
- Support key milestones including FPI, enrollment completion, interim analysis, and database lock
- Lead feasibility assessments and support site selection strategy
- Develop enrollment forecasts and support KOL engagement with Clinical Science
CRO, Vendor & Site Management
- Lead RFP process and vendor selection for CROs and trial partners
- Support contract and budget negotiations
- Provide day-to-day oversight of CROs, vendors, and sites to ensure performance and compliance
Budget Oversight
- Track study budgets and manage vendor spend in partnership with Clinical Operations leadership
Quality & Compliance
- Ensure data integrity and adherence to protocols, SOPs, and ICH-GCP
- Support inspection readiness efforts with Quality Assurance
Operations & Systems
- Help evaluate and implement clinical systems (eTMF, CTMS, RBM, etc.)
- Contribute to SOP development and scalable operational processes
Cross-Functional Collaboration
- Partner with CMC and Clinical Supply Chain to manage drug supply logistics
- Work closely with internal functions to ensure smooth study delivery
Qualifications
Required
- Bachelors degree in scientific or health-related field
- 5–8 years Clinical Operations experience, including 4+ years as a CTM
- Hands-on management of Phase II–III clinical trials
- Knowledge of FDA, EMA, and ICH-GCP guidelines
- Experience with clinical systems (e.g., Medidata Rave, Veeva)
- Experience with study start-up through close-out
- CRO/vendor oversight and clinical trial budget tracking experience
- Strong execution and cross-functional coordination skills
- Comfortable in fast-paced, growth-stage environment
- Excellent communication skills
- Willingness to travel up to ~30%
Preferred
- Global trial experience
- Experience in common disease drug development
Vacancy posted 5 days ago
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