Sr Clinical Project Manager - Early Phase

Position Summary

We are seeking an experienced Clinical Project Manager, Early Phase Clinical Research to lead and oversee Phase I and early development clinical trials from study start-up through closeout. The successful candidate will serve as the primary point of contact for sponsors and internal stakeholders, ensuring studies are delivered on time, within budget, and in compliance with Good Clinical Practice (GCP), ICH guidelines, company SOPs, and regulatory requirements. This role requires strong project leadership, sponsor-facing experience, and a deep understanding of the unique operational challenges associated with early-phase clinical studies, including First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), proof-of-concept, Clinical Pharmacology and other exploratory clinical trials.

Key Responsibilities

Project Leadership & Study Delivery

• Lead all aspects of assigned early-phase clinical trials from study startup through database lock and closeout.
• Serve as the primary liaison between sponsors, internal teams, vendors, and study sites.
• Develop and manage project timelines, milestones, resources, risks, finances, and deliverables.
• Ensure projects are executed according to contractual commitments, study protocols, and operational plans.
• Lead cross-functional project teams to achieve study goals while maintaining quality, timelines, and budget expectations.
• Coordinate activities and deliverables across internal departments and external partners.

Financial & Operational Oversight

• Maintain accountability for overall project financial performance, including budget management, forecasting, and change order identification.
• Monitor project scope and proactively manage risks, issues, and resource requirements.
• Develop contingency plans and risk mitigation strategies to ensure successful study execution.
• Provide regular project status updates and reports to clients and senior leadership.

Quality & Regulatory Compliance

• Ensure studies are conducted in compliance with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements.
• Maintain oversight of Trial Master File (TMF) quality, completeness, and inspection readiness.
• Ensure accurate maintenance of study information within CTMS and other clinical systems.
• Support audit and inspection readiness activities throughout the study lifecycle.
• Maintain accountability for project documentation and all assigned study deliverables.

Client & Stakeholder Management

• Build strong relationships with sponsors through consistent communication and successful project delivery.
• Lead internal and external project meetings, including governance and study team meetings.
• Present project updates, risks, mitigation plans, and key milestones to clients and executive stakeholders.
• Participate in bid defense meetings and support business development initiatives as needed.
• Identify opportunities for future business and expanded client partnerships.

Team Leadership

• Provide leadership and direction to cross-functional study teams.
• Foster collaboration and accountability across operational functions.
• Mentor junior team members and clinical operations staff as appropriate.
• May provide line management responsibilities for project management and clinical monitoring personnel.

What Success Looks Like

• Delivering studies on time, within budget, and with high quality.
• Building trusted partnerships with sponsors and investigative sites.
• Maintaining audit and inspection readiness.
• Proactively identifying and mitigating study risks.
• Successfully leading cross-functional teams through the complexities of early clinical development.