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. Oversee all data management activities across multiple studies—from planning, start-up, conduct, closeout, and archiving. Maintain high data quality through cross-functional review of eCRFs and data structure, edit checks, and collaboration on program-wide data review and cleaning strategies. Assist in creating, implementing, and improving internal and external clinical data management processes with vendors, ensuring completeness, correctness, and consistency of clinical data. Collaborate with clinical development and other applicable functions.

Responsibilities:
- Coordinate assigned programs/studies; oversee internal DM team, CRO partners, and external vendors
- Oversee EDC design (eCRFs, DVS/edit checks, DMP development, eCCGs) and EDC UAT to meet protocol requirements
- Oversee database lock activities to ensure high-quality data, documentation, and inspection readiness
- Partner cross-functionally (Statistical Programming, Biostatistics, Clinical Operations, Medical, Pharmacovigilance, Regulatory) to meet deliverables/timelines
- Provide DM guidance/training to CROs, vendors, investigators, and sites
- Coach/mentor DM team members
- Assist with regulatory submissions from a DM perspective
- Contribute to policies/SOPs and cross-functional standards
- Review/Contribute to clinical documents (protocols, amendments, DSURs, IBs, regulatory updates)
- Ensure DM activities comply with SOPs and remain inspection-ready; maintain eTMF

Qualifications:
- Bachelor’s degree+ (preferably scientific/health)
- 5+ years clinical data management experience in pharma/biotech (preferably sponsor-side)
- Phase I–IV clinical data management expertise
- Experience managing outsourced DM models
- Experience managing clinical data flow across EDC, external data, ePRO/eCOA, specialty data
- Familiarity with GCP/ICH/FDA and other applicable regulations
- Familiarity with CDASH and SDTM
- Excellent written/oral communication and interpersonal skills
- Ability to work independently and with teams/vendors

Preferred:
- CCDM certification

Skills/Tools:
- Strong computer skills; EDC systems and Microsoft Office Suite

Application instructions:
- Encourage to apply