Clinical Project Manager

Senior Clinical Project Manager

Role Summary

The Senior Clinical Project Manager is responsible for leading the end-to-end execution of clinical trials, from study start-up through close-out. This role drives cross-functional collaboration, oversees CROs and vendors, and ensures studies are delivered on time, within budget, and in compliance with regulatory requirements.

Key Responsibilities

• Lead study teams to design, plan, and execute clinical trials aligned with timelines and objectives
• Serve as the primary point of contact for CROs and vendors; provide oversight and performance management
• Coordinate cross-functional activities to ensure proper study conduct and execution
• Monitor study progress, including timelines, budget, and data collection; provide regular updates to leadership
• Ensure trials are conducted in compliance with protocols, GCP, SOPs, and regulatory requirements
• Review and approve study-related documents (protocols, amendments, plans, reports, CSRs)
• Oversee Trial Master File (TMF) to ensure inspection readiness
• Identify risks, manage escalations, and implement mitigation strategies
• Support site selection, feasibility, and investigator engagement
• Contribute to CRO/vendor selection and RFP processes
• Prepare for and support audits and regulatory inspections
• Mentor junior team members and contribute to SOP development and training
• Lead multiple clinical trials simultaneously, as needed

Qualifications

• Bachelor’s degree in health sciences or a related field
• 5+ years of clinical trial management experience (oncology preferred)
• Strong knowledge of ICH-GCP and global clinical trial regulations
• Proven ability to lead cross-functional teams and manage external partners
• Excellent communication, organizational, and problem-solving skills
• High attention to detail with strong project management capabilities
• Proficiency in Microsoft Office tools
• Ability to travel up to 20%