The Clinical Project Manager will lead the planning, execution, and oversight of clinical studies supporting an aesthetic medical device portfolio. This individual will manage study operations from start-up through closeout, ensuring studies meet established timelines, budgets, quality standards, and applicable regulatory requirements.
The ideal candidate combines hands-on clinical operations experience with strong project management skills and the ability to build effective relationships with investigators, study sites, vendors, and cross-functional colleagues. This role requires a proactive, detail-oriented professional who can translate clinical objectives into practical execution plans while prioritizing participant safety and data integrity.
Key Responsibilities
Clinical Study Planning and Execution
- Manage assigned clinical studies throughout the study lifecycle, including feasibility, site selection, start-up, enrollment, follow-up, and closeout.
- Develop and maintain study plans, timelines, budgets, resource forecasts, and risk mitigation strategies.
- Coordinate the development and review of protocols, informed consent forms, case report forms, study manuals, and other essential study documents.
- Track study progress, identify operational barriers, and implement corrective actions to keep projects on schedule.
- Provide clear updates to leadership on milestones, enrollment, spending, risks, and decisions requiring escalation.
Site and Investigator Management
- Serve as a primary operational contact for investigators, research coordinators, and clinical study sites.
- Coordinate site qualification, initiation, monitoring, and closeout activities.
- Ensure site personnel receive appropriate training on protocols, study procedures, documentation, and device handling.
Quality, Compliance, and Participant Safety
- Oversee study execution in accordance with approved protocols, company procedures, and applicable clinical research requirements.
- Partner with Medical, Regulatory Affairs, and Quality Assurance on adverse event documentation, safety escalation, and applicable reporting activities.
- Support audits and inspections and drive timely resolution of findings.
Vendor, Budget, and Cross-Functional Management
- Manage external service providers as needed.
- Coordinate scopes of work, deliverables, vendor performance, purchase orders, and invoice review.
- Contribute to clinical study reports, abstracts, presentations, and publications in collaboration with relevant subject matter experts.
Operational Improvement
- Develop and improve clinical operations templates, tools, workflows, and standard operating procedures.
- Support a culture of collaboration, scientific rigor, continuous improvement, and patient-centered research.
- Bachelor’s degree in a scientific, healthcare, life sciences, or related discipline, or an equivalent combination of education and relevant experience.
- Five or more years of medical device clinical research experience, including at least two years managing clinical studies or substantial clinical study workstreams.
- Working knowledge of Good Clinical Practice and applicable FDA requirements for medical device investigations, informed consent, and institutional review board oversight.
- Demonstrated ability to manage study timelines, budgets, risks, and competing priorities.
- Experience with clinical documentation, monitoring activities, data review, and audit readiness.
- Strong written and verbal communication, organizational, problem-solving, and relationship-management skills.
- Ability to work independently while collaborating effectively across functions.
- Willingness to travel to study sites and company meetings as required.
Preferred Qualifications
- Experience in medical aesthetics, dermatology, plastic surgery, or related procedural specialties.
- Familiarity with standardized clinical photography, blinded assessments, patient-reported outcomes, and aesthetic outcome measures.