The Importance of the Role
The Lead Data Manager, Clinical Data Management is responsible for providing data management expertise, process leadership, and vendor oversight for several studies within a clinical program. The selected candidate will oversee all data management activities across multiple studies; from planning, to start-up, conduct, closeout, and archiving. The candidate will maintain a high level of data quality by ensuring thoughtful and cross-functional review of eCRFs and data structure, corresponding edit checks, and collaboration to create program wide data review and cleaning strategies. The selected candidate will assist in the creation, implementation, and continued improvement of internal and external clinical data management processes with vendors, ensuring completeness, correctness, and consistency of clinical data. This role will collaborate with clinical development team members, and with other functions as applicable.

The Opportunity to Make a Difference

• Project level coordination of assigned programs and studies, including oversight of internal DM team, CRO partners, and other external vendors.
• Oversee directly, or through DM team members, EDC design (including eCRFs, DVS/edit checks, DMP development, eCCGs, etc) and EDC user acceptance testing, to ensure EDC meets protocol requirements for assigned programs and studies.
• Oversee directly, or through DM team members, database lock activities for assigned programs to ensure high quality data with proper documentation and inspection readiness for assigned programs and studies.
• Work collaboratively with Statistical Programming, Biostatistics, Clinical Operations, Medical, Pharmacovigilance, and Regulatory staff to meet program or project deliverables and timelines related to clinical data or clinical data systems.
• Provide DM related guidance and training to CROs, vendors, investigators, and clinical sites, as applicable.
• Provide coaching and mentorship to other DM team members assigned to studies within a clinical program.
• Assist with, from a DM perspective, regulatory submission activities for assigned studies and programs.
• Participate with the development, review, and implementation of policies, SOPs, and associated documents impacting the DM function and responsibilities, and provide input to the development of cross-functional standards and processes.
• Review and contribute to clinical documents such as clinical protocols, protocol amendments, DSURs, IBs, and yearly updates to the regulatory authorities.
• Ensure that all DM activities for assigned studies are compliant with all SOPs and maintained in an inspection ready state at all times.
• Ensure the eTMF is set up and maintained appropriately throughout the duration of the trial.

More about You

• Bachelor's degree or higher, preferably in a scientific area or health related discipline.
• A minimum of 5 years of clinical data management experience in pharma/biotech industry, preferably on the sponsor side.
• Strong expertise in clinical data management for Phase I-IV clinical trials in the pharma/biotech industry.
• Experience managing an outsourced data management model.
• Experienced in managing clinical data flow and associated work processes across all sources of clinical trial data (i.e., EDC, external data, ePRO/eCOA, specialty data).
• Familiarity with GCP, ICH, FDA, and other health authority regulatory requirements as applicable for clinical data management.
• Familiarity with CDASH and SDTM standards.
• Excellent written and oral communication skills.
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
• Ability to collaborate effectively with the study team, cross-functional team members, and external vendors.
• Certified Clinical Data Manager (CCDM) preferred.
• Strong computer skills including strong knowledge of EDC systems and Microsoft Office Suite.

What Now?

We're always looking for solution-oriented, critical thinkers.

So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

#LI-Hybrid

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This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $116,000 - $145,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.