Lead Data Manager, Clinical Data Management

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. Oversees all data management activities across multiple studies (planning, start-up, conduct, closeout, and archiving) and maintains high data quality through cross-functional review of eCRFs and data structure, corresponding edit checks, and program-wide data review/cleaning strategies. Assists in creation, implementation, and continuous improvement of internal and external clinical data management processes with vendors to ensure completeness, correctness, and consistency of clinical data. Collaborates with the clinical development team and other applicable functions.

Responsibilities:
- Coordinate assigned programs/studies, overseeing internal DM team, CRO partners, and other external vendors.
- Oversee EDC design (eCRFs, DVS/edit checks, DMP development, eCCGs, etc.) and EDC user acceptance testing to ensure EDC meets protocol requirements.
- Oversee database lock activities to ensure high-quality data, proper documentation, and inspection readiness.
- Collaborate with Statistical Programming, Biostatistics, Clinical Operations, Medical, Pharmacovigilance, and Regulatory to meet clinical data/system deliverables and timelines.
- Provide DM guidance and training to CROs, vendors, investigators, and clinical sites.
- Coach and mentor other DM team members.
- Assist with regulatory submission activities from a DM perspective.
- Contribute to development/review of policies and SOPs impacting the DM function; provide input on cross-functional standards/processes.
- Review and contribute to clinical documents (protocols, amendments, DSURs, IBs, regulatory updates).
- Ensure DM activities comply with SOPs and remain inspection-ready; ensure eTMF is properly set up and maintained throughout the trial.

Qualifications:
- Bachelor’s degree or higher, preferably in a scientific area or health-related discipline.
- Minimum 5 years of clinical data management experience in pharma/biotech (preferably sponsor-side).
- Strong expertise in clinical data management for Phase I–IV clinical trials.
- Experience managing an outsourced data management model.
- Experience managing clinical data flow across EDC, external data, ePRO/eCOA, and specialty data.
- Familiarity with GCP, ICH, FDA, and other health authority regulatory requirements.
- Familiarity with CDASH and SDTM standards.
- Excellent written and oral communication; strong interpersonal skills; ability to collaborate across teams and vendors.
- Strong computer skills (EDC systems and Microsoft Office Suite).

Preferred:
- Certified Clinical Data Manager (CCDM).

Benefits:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers

Application instructions:
- Hybrid role: expected to work on-site at a U.S. facility and/or attend company-sponsored in-person events.
- Candidates must be authorized to work in the U.S.
- Targeted salary range: $116,000–$145,000 per year.