Sarepta
Senior Clinical Operations Lead
Cambridge, MA · Senior
No sponsorship$152k-$191kDetected 18 days ago
GCPNegotiationFinancial AnalysisForecastingExcelProcurementClinical TrialsClinical ResearchFDA RegulatoryCRISPRResearchLeadershipCommunicationMicrosoft OfficeFinancial Reporting
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.
- Rare disease study management is recommended.
Responsibilities
- Serves as the point of contact for protocol execution and leads the Clinical Trial Team (CTT)
- Works cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated to the Clinical Operations Program Lead (COPL)
- Develops, reviews and/or consults on reports and clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates
- Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed
- In conjunction with CRO and appropriate internal stakeholders, facilitates the development of trial budgets and execution of clinical trial agreements and other relevant documents
- Manages the clinical trial budget and provides financial reporting and projections to Finance
- Leads creation of scope of work and budgets and escalates vendor performance issues to COPL and Procurement as necessary
- Support for Caregivers
Skills
- Experience in management of CROs, vendors and consultants
- Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies
- Proficient written and verbal communication skills
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project
- Position may require some travel
- Bachelor's degree in health sciences or related field
- This position requires work on site at one of Sarepta's facilities in the United States.
- The targeted salary range for this position is $152,400 - $190,500 per year.
- Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.
- Candidates must be authorized to work in the U.S.
- Sarepta Therapeutics offers a competitive compensation and benefit package.
- Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Compensation
- The targeted salary range for this position is $152,400 - $190,500 per year.
Benefits
- Financial Wellness
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.