Clinical Project Manager

Laborie

Maple Grove (MN)

Presencial

USD 110.000 - 150.000

Jornada completa

hace 10 horas
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Ventajas ofrecidas por este puesto de trabajo

Paid time off and paid volunteer time
Medical, Dental, Vision and FSA
Health Savings Account with Company Ff
401k Retirement Plan with CompanyMatch
Parental Leave and Adoption Services
Health and Wellness Programs andEvents
Cigna Healthy Workforce Designation

Descripción de la vacante

Laborie is seeking a Clinical Project Manager to lead clinical study management for product development and lifecycle activities. You will manage timelines, budgets, vendors, and cross-functional teams to deliver compliant studies across stages from start-up to closeout.

Ideal candidates hold a life sciences degree, 5+ years in project management within medical devices or pharmaceutical contexts, and experience with cross-functional product development and regulatory requirements such as GCP.

Formación

  • 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.

Responsabilidades

  • 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 team s ; 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.

Conocimientos

Bachelor’s degree in life sciences
Project management
Cross-functional teamwork
Critical thinking
Problem solving
Travel readiness

Educación

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

Descripción del empleo

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

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 . T his 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 team s ; 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 202 5 Cigna Healthy Workforce Designation Gold Level

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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