Lead Clinical Data Manager

📋 Description

• Lead sponsor-side data management for Phase 2/3 trials in rare disease and neonatology.
• Develop and execute data management strategies aligned with development timelines.
• Primary contact for DM deliverables across internal and external partners.
• Oversee DM activities by CROs and other vendors in outsourced model.
• Manage vendor relationships with CROs, EDC providers, central labs, imaging vendors.
• Lead data governance meetings and escalate risks and issues as appropriate.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Biostatistics, CS, Nursing, or Public Health; advanced degree preferred.
• 12-15 years clinical data management in biotech/pharma/CRO.
• Experience leading global Phase 2/3 trials.
• DM activities for inspection readiness.
• Sponsor-side experience in outsourced DM model.
• Experience supporting NDA/BLA/MAA submissions and related studies.

🎁 Benefits

• Fully remote role with global team.
• Mon–Fri EST schedule.
• Impactful work in rare diseases and neonates.
• Collaborative, cross-functional environment.