Key Elements and Responsibilities
· Provide strategic and operational leadership for clinical operations and data management across programs, from study start-up through close-out, in compliance with ICH-GCP.
· Ensure the quality, integrity, and inspection-readiness of all clinical and data management activities globally.
· Drive cross-functional collaboration to deliver clinical trials on time and within budget.
· Lead planning, execution, and reporting of clinical studies, ensuring alignment on timelines, deliverables, and resources.
· Act as the primary escalation point for critical study and vendor issues.
· Oversee study budgets, timelines, resources, and financial tracking.
· Partner with Clinical Science, Biostatistics, and external vendors to ensure seamless delivery of:
o Data management activities
· Ensure effective coordination of regulatory submissions (e.g., IRB/ethics committees, local authorities).
· Oversee data management strategy and execution, including database design, build, maintenance, and database lock activities, in alignment with biostatistics.
· Ensure robust data integrity, accurate record-keeping, and compliant archiving practices.
· Provide oversight of clinical sites, academic partners, and vendors (e.g., CROs, labs) to ensure performance, quality, and compliance.
· Build and maintain strong relationships with investigators and key opinion leaders.
· Lead, develop, and mentor high-performing teams.
· Ensure delivery of high-quality study documentation to meet program timelines.