Senior Clinical Project Manager

The Senior Clinical Project Manager (Sr. CPM) provides strategic and operational leadership for complex clinical trials across multiple phases. This role is accountable for study delivery, financial oversight, cross-functional leadership, and sponsor relationship management, ensuring clinical programs are executed on time, within budget, and in full regulatory compliance.

• Lead and oversee complex Phase I–IV clinical trials, including global and multi-study programs
• Own study strategy, execution plans, timelines, budgets, and risk management
• Serve as primary escalation point for study issues and sponsor communications
• Drive decision-making to resolve operational, quality, and timeline challenges
• Lead cross-functional study teams (Clinical Operations, Data Management, Biostatistics, Medical, Regulatory, Safety)
• Manage and oversee CROs, central labs, vendors, and third-party providers
• Ensure vendor performance aligns with contracts, KPIs, and quality expectations
• Develop, manage, and forecast study budgets and financials
• Monitor burn rates, change orders, and contract amendments
• Optimize resource allocation across studies and programs

• Ensure compliance with ICH-GCP, FDA regulations, global regulatory requirements, and company SOPs
• Lead inspection readiness activities and support regulatory audits and health authority inspections
• Ensure high-quality study documentation and TMF completeness

• Mentor and guide Clinical Project Managers and Associate Project Managers
• Contribute to process improvements, SOP development, and best practices
• Support business development activities, including proposal development and feasibility assessments

• Bachelor’s degree in Life Sciences or related field (required)
• Master’s degree or advanced clinical research certification (preferred)

• 8–12+ years of clinical research experience
• 5+ years of clinical project management experience in pharma, biotech, or CRO
• Proven experience managing global, multi-center clinical trials
• Experience leading cross-functional teams and external vendors
• Advanced knowledge of clinical development and trial execution
• Strong leadership, strategic thinking, and decision-making skills
• Excellent stakeholder, sponsor, and executive communication abilities
• Deep understanding of clinical trial budgeting and financial management
• Proficiency with clinical trial systems and project management tools
• PMP, PgMP, or equivalent certification (preferred)