Senior Clinical Trial Manager
$110,000–$135,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Plan and manage global clinical trials, including timelines, budgets, resources, and key deliverables, while leading cross-functional teams to ensure adherence to SOPs, regulatory requirements, and ICH/GCP guidelines. Collaborate with clinical scientists on trial design, establish milestones with outsourcing managers, and oversee Clinical Research Associates and CROs. Proactively identify risks, mitigate program issues, and prepare for regulatory inspections. Contribute to reporting and documentation for regulatory submissions throughout the development life cycle. Manage contract research organizations and functional service providers in partnership with procurement.
Required Qualifications
- University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences
- Progressive experience in clinical research/operations (at least 5 years)
- Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports
- Experience as manager of clinical trials in major market(s) such as US, China
- Experience in supervising CROs
- Excellent understanding of the drug development process
- systemic drug and biologics experience
- Excellent knowledge of international ICH/GCP guidelines
- basic knowledge of GMP/GDP
- Excellent knowledge of relevant local regulations
- Fluent in English (written and oral)
- Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally
- Travel estimated at 20%
Desired Qualifications
- Excellent understanding of the drug development process, systemic drug and biologics experience preferred
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