Clinical Project Manager
About The Position
The Clinical Project Manager serves as the clinical study manager for assigned investigations and is responsible for planning, execution, oversight, and delivery of studies that support product development, regulatory submissions, post-market evidence generation, and lifecycle management. The role leads cross-functional study teams, manages timelines, budgets, vendors, and risks, and ensures studies follow applicable regulations, Good Clinical Practice (GCP), and company procedures. The position leads study activities from start-up through closeout, maintains project plans and study metrics, coordinates investigators and stakeholders, and monitors study progress, expenditures, and resource use. It represents Clinical Affairs on product development and lifecycle management teams, contributes to clinical evidence planning and study design, and supports assessments of product concepts and strategic business initiatives.
Requirements
- Bachelor’s degree in life sciences, health sciences, nursing, clinical research, public health, biomedical engineering, or a related discipline.
- At least 5 years of project management experience or demonstrated ability to lead and align teams to achieve project milestones.
- Experience in the medical device or pharmaceutical industry and working knowledge of medical device regulations.
- Experience participating on cross-functional product development or product lifecycle management teams.
- Strong project planning and management, critical thinking, decision-making, and problem-solving skills.
- Ability to travel as needed.
Nice To Haves
- Advanced degree.
- Clinical research, project management, or related professional certification, such as 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 in Gastroenterology, Urology, Pelvic Health, Maternal and Child Health, or related therapeutic areas.
Responsibilities
- Lead study execution 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 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 stakeholders to define clinical evidence requirements and priorities.
- Provide input into study concepts, research questions, feasibility assessments, and clinical evidence requirements.
- Contribute to clinical study design, protocol development, endpoint selection, and evidence generation plans.
- Support clinical assessments and evidence reviews for new product concepts and strategic business initiatives.
Benefits
- Paid time off
- Paid volunteer time
- Medical, dental, and vision coverage
- Flexible Spending Account
- Health Savings Account with company-funded contributions
- 401(k) retirement plan with company match
- Parental leave
- Adoption services
- Health and wellness programs and events
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
