Clinical Project Manager in WOBURN, Massachusetts at Cytrellis Biosystems Inc

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.