Sarepta

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.

This listing is sourced directly from Sarepta's careers page and normalized into a canonical job model.