Director, IT R&D and Quality Applications

📋 Description

• Lead IT partner across Clinical Ops, Data Management, Biometrics.
• Oversee systems for regulatory submissions, pharmacovigilance, and quality.
• Support trials with decentralized models, diaries, and connected devices.
• Lead RD systems (CTMS, EDC, eTMF, ePRO/eCOA, IRT, analytics).
• Spearhead AI enablement within RD, Clinical & Quality systems.
• Develop integration strategy across clinical data ecosystems (Veeva Vault R&D Suite).

🎯 Requirements

• Bachelor’s degree in computer science, Life Sciences, or related field.
• 10+ years of Life sciences business applications with 5+ years in RD/Clinical systems.
• Experience with clinical trial systems (CTMS, eTMF, eCRO, ePRO).
• Deep expertise in Veeva Vault R&D Suite (Clinical, RIM, Quality, Safety).
• Strong knowledge of GxP regulations, CDISC SDTM/ADaM and Computer System Assurance.
• Experience managing cross-functional teams and SaaS-based vendors.

🎁 Benefits

• Remote work opportunities within the United States.
• Occasional travel to Cambridge, MA for company events.