Lead Data Manager, Clinical Data Management

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.

• 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.
• Aid 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.
• 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.
• Collaborate 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.

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.

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.
• Familiarity with GCP, ICH, FDA, and other health authority regulatory requirements as applicable for clinical data management.
• Familiarity with CDASH and SDTM standards.

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.

Pay

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.

Schedule

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.