Senior Clinical Project Manager

What You Will Be Doing

• Independently lead the clinical trial study team and manage global clinical trial activities from start-up through study closeout.
• Communicate and guide the activities of the clinical team members, ensuring compliance with the protocol, GCP, and local regulations.
• Partner with R&D, Regulatory, Quality, and Marketing/Product stakeholders, supporting regulatory processes with writing, strategy development, and corrective actions.
• Manage all clinical studies, including developing project management plans, strategy, cost, and timelines; identifying, qualifying, and training investigators and their teams; contributing to protocol writing/amendments; and preparing annual progress reports and final study reports.
• Manage Institutional Review Board (IRB)/Ethics Committee (EC) processes and clinical study vendors (e.g., core labs, statistical consultants).
• Develop and manage Site Activation Plans, ensuring site selection, IRB/EC approval, and vendor contracts.
• Ensure data integrity and manage data lock processes, including SAE narrative development for DSMB review and safety profile oversight.
• Build and maintain strong relationships with Principal Investigators and coordinators to foster trust and collaboration.
• Ensure timely submission of annual regulatory reports and support the preparation of registration packages and activities requiring regulatory agency approvals.
• Support the development of conference abstracts and peer-reviewed publications, presenting as applicable.

Qualifications

• Bachelor’s degree in a Life Sciences discipline required; Master’s degree or other advanced scientific/clinical qualification preferred.
• Exceptional proficiency in professional English, with advanced medical and scientific writing skills, including development of clinical protocols, clinical study reports (CSRs), safety reports, annual regulatory reports, informed consent forms (ICFs), case report forms (CRFs), and other regulatory-compliant clinical trial documentation.
• Demonstrated experience authoring clinical study protocols and contributing to clinical sections of regulatory submissions, including PMA and/or 510(k) applications.
• Strong presentation and communication skills, with experience delivering scientific and clinical information to investigators, key opinion leaders, clinical study teams, senior management, and at Clinical User Meetings.
• Comprehensive knowledge of the medical device clinical trial lifecycle, from study concept and design through study execution, data analysis, CSR preparation, and regulatory submission support.
• In-depth understanding of medical device clinical research, including operational, regulatory, and quality requirements, with thorough knowledge of Good Clinical Practice (GCP), FDA regulations, ISO 14155, and applicable global medical device regulations.
• Solid understanding of biostatistics and clinical data interpretation, with the ability to critically evaluate scientific literature and effectively communicate statistical outcomes in clinical and regulatory documents.
• Minimum of 5–6 years of progressive experience in clinical project management, including oversight of IDE, IND, Class III medical device, and/or drug-device combination product studies.
• Experience working directly with regulatory authorities, including FDA, notified bodies, and international regulatory bodies, supporting study submissions, approvals, and ongoing regulatory interactions.
• Proven ability to manage and oversee external clinical vendors, including contract research organizations (CROs), biostatistical consultants, core laboratories, data management providers, Clinical Events Committees, and Data Safety Monitoring Boards (DSMBs).
• Strong knowledge of U.S., EU, Japan clinical trial regulations and processes; experience with international clinical research regulations and global study execution is highly desirable.
• Recognized subject matter expertise in regional clinical research regulations and compliance requirements.
• Excellent organizational, leadership, and stakeholder-management skills, with the ability to manage multiple complex projects in a fast-paced environment.
• Willingness and ability to travel as required, up to 35% of the time, to support investigator meetings, site initiation visits, and support monitoring where needed.