Senior Clinical Trial Manager, Cambridge, MA
Isomorphic Labs · Cambridge, MA
Clinical OperationsCompany career page
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Role summary
Isomorphic Labs seeks a Senior Clinical Trial Manager to lead cross-functional teams through all phases of the clinical trial lifecycle, from start-up through close-out. The role requires managing trial operations to ICH/GCP standards, overseeing vendor and site relationships, and collaborating with the Head of Clinical Operations as the clinical department expands.
What they're looking for
- Experience executing clinical trial start-up, conduct, and close-out activities
- Proficiency with ICH/GCP Guidelines and regulatory standards
- Demonstrated ability to manage cross-functional teams and build vendor relationships
- Strategic thinking with strong problem-solving and adaptability skills
- Experience managing change orders, contracts, and vendor invoicing
What you'll be doing
- Lead cross-functional teams through complete clinical trial lifecycle management
- Oversee study start-up, maintenance, and close-out activities to regulatory standards
- Manage vendor contracts, change orders, and cost tracking for clinical trials
- Contribute to development of regulatory documents including protocols and clinical summaries
- Develop training materials and trial-specific documentation for sites and staff
Privacy & handoff
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