- Provide strategic operational leadership and oversight for a key clinical program, ensuring alignment with clinical development objectives and corporate goals
- Oversee CROs and vendors, leading governance and partnering closely to ensure accountability for delivery of operational activities, timelines, quality, and budget, and driving proactive risk management and mitigation across the study
- Lead study-specific and cross-functional meetings, driving clear decisions, accountability, and timely issue resolution
- Collaborate cross-functionally (Clinical, Regulatory, Translational, Data Management, Biostatistics) to ensure integrated and efficient study execution
- Oversee study progress and performance using key metrics (e.g., enrollment, eligibility, data quality, primary endpoints), ensuring transparent communication and a solution-oriented approach
- Proactively identify, assess, and manage study and program-level risks, including mitigation planning and escalation of critical issues
- Ensure data quality, integrity, and completeness to support analyses, regulatory submissions, and program decision-making
- Establish and oversee vendor governance, including performance management, SOW/budget review, and financial tracking (forecasts, accruals)
- Ensure inspection readiness, including TMF quality, audit preparedness, and compliance with GCP and internal SOPs
- Build and maintain strong relationships with investigators, study staff, and external partners, and represent Clinical Operations in internal governance and external interactions
GCPRisk Management