As a key member of the Clinical team, the Clinical Project Manager will serve as the clinical study manager for assigned investigations, with overall responsibility for the planning, execution, oversight, and delivery of studies supporting product development, regulatory submissions, post-market evidence generation, and lifecycle management activities. This role leads cross-functional study teams, manages timelines, budgets, vendors, and risks, and ensures clinical investigations are conducted in compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures.
About the Role:
- Lead study execution activities from study start-up through study closeout; develop and maintain timelines, project plans, budgets, study metrics, and risk management plans.
- Coordinate study activities across investigators and key stakeholders, monitor study progress, expenditures, and resource utilization; facilitate study meetings and provide regular updates.
- Represent clinical affairs on product development and lifecycle management core teams; partner with key stakeholders to define clinical evidence requirements and priorities.
- Provide clinical affairs input into study concepts, research questions, feasibility assessment, and clinical evidence requirements for assigned programs; support evaluation of opportunities for new indications, expanded claims, product enhancements, and geographical market expansion.
- Contribute to clinical study design, protocol development, endpoint selection, and evidence generation plans supporting product development, regulatory objectives, and commercial strategies.
- Support clinical assessments and evidence reviews associated with new product concepts and strategic business initiatives.
Minimum Qualifications:
- Bachelor's degree in life sciences, health sciences, nursing, clinical research, public health, biomedical engineering, or a related discipline.
- 5+ years project management experience or a demonstrated ability to lead and align teams to achieve project milestones.
- Experience working in field of medical devices or pharmaceutical industry and working knowledge of medical device regulations.
- Experience participating on cross-functional produce development or product lifecycle management teams.
- Strong project planning and management, critical thinking, decision making, and problem solving.
- Ability to travel as needed.
Preferred Qualifications:
- Advanced degree preferred.
- Clinical research, project management, or related professional certification (ACRP, SOCRA, PMP, or equivalent).
- Experience with statistical methods, interpretation and data collection techniques.
- Demonstrated experience managing clinical studies from initiation through completion.
- Experience contributing to study design, protocol development, and clinical evidence generation activities.
- Experience working with contract research organizations (CROs), investigators, research sites, and external vendors.
- Experience within Gastroenterology, Urology, Pelvic Health, Maternal and Child Health, or related therapeutic areas.
Why Laborie:
Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
- Paid time off and paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events
- Awarded 2025 Cigna Healthy Workforce Designation Gold Level
