Senior Clinical Project Manager (United States)

Senior Clinical Project Manager / Global Study Manager

Global Clinical Development

Position Summary

The Senior Clinical Project Manager (CPM) / Global Study Manager provides strategic and operational leadership for global clinical trials. This role is responsible for end-to-end study execution, cross-functional coordination, and oversight of CROs and vendors to ensure clinical programs are delivered on time, within budget, and in full compliance with regulatory and quality requirements.

This position is well suited for a hands-on clinical operations leader who thrives in a fast-paced environment and brings strong experience managing complex, multi-regional clinical trials.

Key Responsibilities

• Lead the planning, execution, and delivery of global clinical trials from study start-up through close-out
• Serve as the primary operational lead for assigned studies, ensuring adherence to timelines, milestones, budgets, and quality standards
• Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Safety, CMC, and other internal teams
• Manage and oversee CROs, vendors, and external partners, including performance oversight, issue resolution, and continuous improvement
• Develop and maintain comprehensive study plans, timelines, risk mitigation strategies, and operational metrics
• Ensure compliance with ICH-GCP, internal SOPs, and applicable global regulatory requirements
• Identify, assess, and proactively manage study risks, operational challenges, and scope changes
• Contribute to protocol development, feasibility assessments, and overall study strategy
• Support inspection readiness activities and participate in audits and regulatory inspections as needed
• Mentor and support junior team members and contribute to operational excellence and process improvement initiatives

Qualifications

Education

• Bachelor’s degree in life sciences or a related field required
• Advanced degree preferred

Experience

• 8+ years of clinical operations experience, with at least 5+ years leading global clinical trials
• Prior experience in a sponsor or biotech environment strongly preferred
• Demonstrated success managing Phase I–III clinical studies (phase focus may vary based on program needs)
• Strong experience overseeing CROs and global vendors
• Proven ability to manage complex, multi-regional studies across the U.S., Europe, APAC, and other regions

Core Competencies

• Excellent communication, leadership, and stakeholder management skills
• Highly organized, detail-oriented, and able to manage ambiguity in a dynamic environment
• Ability to work independently while collaborating effectively across cross-functional teams