Sarepta
Lead Data Manager, Clinical Data Management
Cambridge, MA · Staff+
No sponsorship$116k-$145kDetected 30 days ago
Data StructuresGCPClinical TrialsFDA RegulatoryCRISPRPharmacovigilanceLeadershipCommunicationCollaborationMentoringMicrosoft OfficeBiostatistics
About the role
- The promise of genetic medicine has arrived, and Sarepta is at the forefront.
- In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
- The selected candidate will oversee all data management activities across multiple studies; from planning, to start-up, conduct, closeout, and archiving.
Responsibilities
- Project level coordination of assigned programs and studies, including oversight of internal DM team, CRO partners, and other external vendors.
- Review and contribute to clinical documents such as clinical protocols, protocol amendments, DSURs, IBs, and yearly updates to the regulatory authorities.
- Support for Caregivers
- Ability to collaborate effectively with the study team, cross-functional team members, and external vendors.
Compensation
- The targeted salary range for this position is $116,000 - $145,000 per year.
Benefits
- Bachelor's degree or higher, preferably in a scientific area or health related discipline.
- Financial Wellness
- Familiarity with GCP, ICH, FDA, and other health authority regulatory requirements as applicable for clinical data management.
Visa & Work Authorization
- Candidates must be authorized to work in the U.S.
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This listing is sourced directly from Sarepta's careers page and normalized into a canonical job model.