The Clinical Project Manager is responsible for planning, managing, and executing medical device clinical studies from start to finish. This includes study design support, site activation, study oversight, compliance management, and study closeout. The role ensures studies are completed on time, within budget, inspection-ready, and compliant with regulatory and quality standards. The CPM works cross-functionally and manages CROs, vendors, and clinical sites to support both pre-market and post-market clinical evidence needs.
The Clinical Project Manager leads end-to-end execution of clinical trials, ensuring operational excellence, regulatory compliance, and high-quality data delivery. This role manages timelines, budgets, vendors, risk mitigation, and cross-functional communication throughout the study lifecycle.
Lead site feasibility, selection, and investigator qualification activities.
Support development and review of study documents (protocols, informed consent forms, monitoring plans, CRFs, EDC input, study manuals).
Coordinate study start-up activities including vendor selection, contracts, IRB/EC submissions, site activation, and study training.
Partner with Medical Affairs and Regulatory teams to support U.S. and global regulatory submissions.
Provide full operational oversight of clinical studies across sites and vendors.
Track enrollment, timelines, milestones, and study metrics.
Manage CRO/vendor performance and lead governance meetings.
Identify risks early and implement mitigation strategies.
Deliver executive-ready study updates, dashboards, and status reports.
Ensure compliance with GCP, regulatory requirements, and internal SOPs.
Oversee TMF/eTMF documentation to maintain audit readiness.
Manage protocol deviations and support CAPA activities.
Coordinate with Quality and Safety teams on adverse event reporting and reconciliation processes.
Support clinical data review, cleaning, and interpretation.
Contribute to clinical study reports and regulatory documentation.
Compile post-market clinical data to support lifecycle management.
Assist with documentation for Design History File (DHF) and regulatory filings.
Support other company-sponsored clinical initiatives as needed.
Bachelor’s degree (Life Sciences preferred) or equivalent experience.
5+ years of clinical research experience (medical device or pharmaceutical).
2+ years of direct project management experience preferred.
Experience managing CROs, vendors, and multi-site studies preferred.
Experience with device trials and IRB/EC processes required (IDE experience a plus).
Endocrinology or diabetes experience highly preferred.
Strong analytical, organizational, and interpersonal skills.
Knowledge of regulatory guidelines and compliance requirements.
Strong project management and execution skills.
Excellent written and verbal communication abilities.
Risk identification and problem-solving mindset.
Proficient in Microsoft Office and clinical trial systems (EDC, eTMF).
Able to work in fast-paced, cross-functional environments.
Approximately 10% domestic and international travel.
Hybrid role – may require occasional work from company office, clinical trial sites, or remote locations.