Senior Clinical Trial Manager
Company: MK
- Location: Los Angeles, United States
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
The Senior Clinical Trials Manager oversees Phase 1–3 clinical trials from planning through closeout, ensuring studies meet timelines, budgets, quality standards, protocols, GCP, and applicable regulatory requirements. This role collaborates with internal teams, CROs, vendors, and investigational sites to support successful trial execution.
Key Responsibilities
- Manage trial operations, timelines, budgets, enrollment, and data collection. Identify risks and implement solutions.
- Support CRO, vendor, and site selection; oversee performance, deliverables, and regulatory compliance.
- Coordinate cross-functional teams and serve as a resource for investigational sites.
- Develop and review study documents, operational plans, case report forms, and informed consent materials. Support EDC development and user acceptance testing.
- Review monitoring reports, audit findings, and trial files; participate in site initiation and co-monitoring visits as needed.
- Support SOP development, process improvements, and staff training.
- Occasional travel to Southern California offices.
Qualifications
- Bachelor’s degree and at least nine years of relevant pharmaceutical or biotechnology clinical trial experience.
- Demonstrated experience managing Phase 1–3 trials, with knowledge of drug development, clinical monitoring, data management, safety, and regulatory processes.
- Strong knowledge of FDA regulations, ICH guidelines, and GCP.
- Experience managing CROs and vendors, negotiating contracts, and overseeing budgets.
- Excellent organizational, communication, problem-solving, and technical document review skills; ability to manage competing priorities.
- Proficiency in Microsoft Office and Microsoft Project.
- Willingness to travel 10–15%.
Full details provided to qualified candidates
