Lead Data Manager, Clinical Data Management

Sarepta Therapeutics • Cambridge, MA

1d • $116,000 - $145,000 • Hybrid

About The Position

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.

Requirements

• 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.
• Strong computer skills including strong knowledge of EDC systems and Microsoft Office Suite.

Nice To Haves

• Certified Clinical Data Manager (CCDM) preferred.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level