About the role

What you’ll do

• Serve as strategic IT partner to Clinical Development
• Lead GCP systems and clinical data centralization initiatives
• Align technology capabilities and business processes with regulatory requirements
• Translate business strategy into technology roadmaps and solutions
• Support computerized system validation and GCP audits/inspections
• Manage technology vendors and complex cross-functional initiatives

What you’ll need

• Bachelor's degree in Information Systems, Life Sciences, Data Science, Engineering, or related field; Master's degree preferred
• 8+ years of experience in information systems, business analysis, or technology delivery in biotech, pharmaceutical, or CRO environments
• Experience with GCP systems such as CTMS, eTMF, clinical data repositories, SAS environments, IRT/RTSM, or safety systems
• Knowledge of GCP regulations including ICH E6(R3), 21 CFR Part 11, EU Annex 11, ALCOA+, and GAMP 5
• Experience leading business process analysis, fit/gap assessments, requirements definition, and computerized system validation
• Strong stakeholder management and ability to influence without authority across Clinical, Quality, IT, CROs, and vendors

Original job description