Senior Manager, Clinical Research Support

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
 

We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
 

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• ​Financial Wellness

• Support for Caregivers
   

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
 

The Importance of the Role

This role will serve as a leader for the Research Operations Clinical Trial Support function and is responsible for planning, implementation, execution, and oversight of specialty clinical lab testing (conducted internally and externally) in partnership with subject matter experts from Translational Biology, Immunology, and Genomics. The individual will also oversee and/or provide input on vendor selection and contracting, sample management and reconciliation, clinical site training, and site feasibility. The position will work cross-functionally with Clinical Operations, Project Management, Compliance, Data Management and other teams supporting clinical trial execution.

The Opportunity to Make a Difference

• Provide comprehensive oversight of specialty lab vendors in partnership with Translational Biology, Immunology, and Genomics subject matter experts
• Partner with internal teams involved in conducting clinical sample testing to ensure communication and alignment on deliverables, sample tracking, and appropriate documentation
• In collaboration with Project Management and Clinical Operations, ensure vendors and internal teams are executing on analysis timelines and any risks are appropriately flagged and mitigated
• May participate in the Clinical Trial Team (CTT) and/or the program Clinical Sub Team
• Oversee direct reports, providing growth opportunities and training and ensuring alignment and harmonization on study management processes
• Contribute to and maintain updates of key metrics/KPIs associated with the Clinical Support function and vendors
• Ensures adherence to ICH/GCP/GLP/Federal and local regulations and company specific SOPs
• Develop, review and/or author documents including but not limited to: clinical trial protocols, lab manuals, clinical allocation and blinding protocols, regulatory submissions, training materials, SOPs
• Conduct 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, or delegates activity with oversight
• Oversee specialty lab vendor budgets and agreements and provides financial reporting and forecasts to Finance and Accounting
• Requests and/or reviews scope of work agreements and budgets and escalates vendor performance issues as needed
• Assume leadership role in operational or process improvement initiatives (e.g. sample shipment tracking, consent verification process, ICF tracking, LIMS deployment)

More about You

• Experience in management of CROs, vendors and consultants and/or experience with Translational/Biomarker/Bioanalytical lab management
• Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines
• Adaptable and able to balance and manage multiple priorities
• Strong written and verbal communication skills and attention to detail
• Ability to collaborate effectively with cross-functional team members and external partners (including investigator and site staff)
• Strong computer skills including proficiency with Excel, Word, PowerPoint, Outlook
• Bachelor’s degree in