The Senior Clinical Project Manager (PM) supports/is responsible for the overall project coordination and management of clinical studies, including all project deliverables, from start up through close out activities. This is accomplished by ensuring all projects are completed on-time and on-budget within the scope of the client agreements. The PM is responsible for the cross-functional team's compliance with project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, and other applicable regulations. The PM is also responsible for managing study staff and across department initiatives while maintaining client satisfaction.
Essential Duties and Responsibilities- Lead the initiation, planning, execution, and closeout of clinical studies, ensuring adherence to timelines, budgets, and quality standards.
- Serve as a client-facing representative; coordinate and lead project meetings, develop agendas, and issue meeting minutes.
- Develop and maintain core study documentation including Project Management Plans, Communication Plans, Risk Logs, timelines, and milestone trackers.
- Manage study budgets, proposals, contracts, and out-of-scope documentation; support financial tracking and invoicing processes.
- Support start-up activities including collection of CDAs, feasibility information, budgets, and CTAs; maintain regulatory and study files.
- Coordinate with functional teams to allocate resources and balance workload across the project.
- Identify project risks and delays; implement contingency and risk-control measures.
- Oversee TMF management to ensure organization, accuracy, and inspection readiness.
- Manage vendors and ensure their deliverables align with study requirements and quality expectations.
- Support preparation of clinical reports and key study documentation.
- Ensure compliance with SOPs, regulatory guidelines, and study-specific training requirements.
- Perform additional project-related duties as assigned.
Qualifications- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
- Minimum of 3 years relevant clinical research industry experience
- Project Manager experience commensurate with years in the industry, and sufficient to successfully perform key responsibilities
- Supervisory experience
- Advanced knowledge of GCPs, ICH guidelines, FDA and other applicable regulations.
- Intermediate knowledge of project management techniques
- Proficient in Microsoft Office, Adobe and Project Management software
- Strong interpersonal skills with the ability to work with all levels of management and employees; ability to gain credibility, provide effective customer service, and foster positive working relationships with internal and external stakeholders
- Ability to function independently in a fast-paced team environment
- Effective verbal and writing skills; English proficiency
- Ability to travel 10-20%
