Clinical Project Manager
Fully Remote • WOBURN
Description

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. 
Requirements
  • 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.