Clinical Project Manager

Laborie Medical Technologies Corp•Maple Grove, MN

10d

About The Position

As a key member of the Clinical team, the Clinical Project Manager serves as the clinical study manager for assigned investigations, with overall responsibility for planning, execution, oversight, and delivery of studies supporting 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 clinical investigations comply with applicable regulations, Good Clinical Practice (GCP), and company procedures. The position leads study execution from start-up through closeout and represents Clinical Affairs on product development and lifecycle management core teams. It partners with stakeholders to define clinical evidence requirements and priorities, contributes to study concepts and design, and supports clinical assessments and evidence reviews for product concepts and strategic business initiatives. Travel may be required as needed.

Requirements

Bachelor’s degree in life sciences, health sciences, nursing, clinical research, public health, biomedical engineering, or a related discipline.
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 (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.

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 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 stakeholders to define clinical evidence requirements and priorities.
Provide Clinical Affairs input into study concepts, research questions, feasibility assessments, 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.
Ensure clinical investigations are conducted in compliance with applicable regulations, GCP, and company procedures.