Lead Clinical Data Manager
O
Oak Hill BioBiotechnology, Pharmaceuticals
India, Monday–Friday, 8:00 AM – 5:00 PM ESTFull-TimeLead
Salary not disclosed
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Job Details
- Experience
- 12-15 years
- Required Skills
- GCP
Requirements
- Bachelor's degree in Life Sciences, Biostatistics, Computer Science, Nursing, Public Health, or a related discipline.
- Minimum 12-15 years of clinical data management experience within the biotechnology, pharmaceutical, or CRO industry.
- Demonstrated experience leading global Phase 2/3 clinical trials.
- Significant sponsor-side experience operating within a fully outsourced clinical development model.
- Experience leading DM activities for inspection readiness.
- Experience supporting regulatory submissions (NDA, BLA, MAA).
- Prior experience with rare disease, pediatric, or neonatal clinical studies.
- Strong knowledge of EDC platforms such as Medidata Rave, Oracle InForm, or Veeva Vault CDMS.
- Experience with CDISC standards, including SDTM and controlled terminology.
- Familiarity with eCOA, laboratory data transfers, and safety reconciliation.
- Strong leadership and vendor-management skills within a matrixed environment.
Responsibilities
- Lead all sponsor-side data management activities for Phase 2/3 clinical trials in rare disease and neonatology.
- Develop and execute data management strategies aligned with clinical development, regulatory, and submission timelines.
- Manage relationships and performance of CROs, EDC providers, central laboratories, and other specialty vendors.
- Review and approve key documents such as DMPs, Data Validation Plans, and UAT documentation.
- Oversee database build, testing, deployment, maintenance, and database lock activities.
- Ensure data quality, review, query management, coding, and reconciliation are performed in accordance with GCP.
- Maintain inspection readiness and support regulatory submissions including NDA/BLA/MAA packages.
- Partner with cross-functional teams to assess protocol feasibility and identify operational risks.
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