Clinical Trial Planning & Execution

• Lead end-to-end management of clinical trials across all phases (Phase I–IV or device studies)

• Develop and maintain project plans, timelines, milestones, and deliverables

• Ensure trials are executed in accordance with protocol, ICH-GCP, regulatory requirements, and SOPs

• Track study progress and proactively manage risks, issues, and dependencies

Cross-Functional Team Leadership

• Lead and coordinate cross-functional teams including CRAs, data management, biostatistics, safety, regulatory, vendors, and investigators

• Facilitate study team meetings, governance reviews, and sponsor updates

• Provide direction, coaching, and oversight to CRAs and study team members

Budget, Vendor & Resource Management

• Develop and manage study budgets, forecasts, and cost controls

• Oversee CROs, central labs, imaging vendors, and other third-party service providers

• Track vendor performance, deliverables, and contract compliance

Study Start-Up & Site Oversight

• Oversee feasibility, site selection, site activation, and enrollment strategies

• Ensure timely collection and maintenance of regulatory documents in eTMF

• Monitor site performance metrics including enrollment, retention, and data quality

Risk Management, Quality & Compliance

• Implement risk-based monitoring (RBM) strategies and quality management plans

• Ensure studies are inspection-ready at all times

• Support audits, regulatory inspections, and health authority interactions

• Drive CAPA development and implementation when issues are identified

Reporting & Stakeholder Communication

• Provide accurate and timely study status reports to internal leadership and sponsors

• Communicate risks, mitigation strategies, and change impacts effectively

• Maintain transparent documentation and decision logs