Technical Project Manager – Clinical Trials

About the role

The Technical Project Manager will lead end‑to‑end delivery of technical components for clinical trials within a drug or vaccine program. You will create and execute detailed project plans, coordinate cross‑functional resources, and ensure all technical deliverables meet quality and regulatory standards.

Key responsibilities

• Build and maintain comprehensive plans for design, build, testing, deployment, operation and close‑out of study‑level technical deliverables such as eCRFs, data‑collection systems, integrations, edit checks, reports, and archival processes.
• Lead discovery workshops with study stakeholders and subject‑matter experts to define technical requirements, timelines and service scope.
• Ensure consistent application of clinical database standards and manage change‑request intake and processing.
• Orchestrate configuration and build activities with full traceability to requirements, providing status reporting and governance updates.
• Triage defects, manage change requests, and maintain audit‑ready documentation throughout the study lifecycle.
• Serve as the primary technical point of contact for each trial, representing Global Clinical Data Integration on cross‑functional teams.
• Validate that all technical components are production‑ready before first‑patient‑first‑visit and support end‑of‑study archival and decommissioning.
• Support audits and inspections, ensuring validation evidence meets SOP/GxP expectations.

Required profile

• Proven experience managing technical projects for clinical trials or similar regulated environments.
• Strong knowledge of clinical database standards, GxP compliance and data‑management procedures.
• Ability to work with cross‑functional stakeholders, drive decision‑making and manage risk and change.
• Excellent organizational and documentation skills to maintain audit‑ready records.

Required skills

• eCRF design and development
• Clinical data management systems
• GxP compliance
• Risk and change management
• Audit documentation preparation