Clinical Project Manager

3 weeks ago

Minnetonka, United States Laborie Medical Technologies Corp Full time

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 Research team, the Clinical Project Manager will oversee the planning, coordination, and execution of clinical projects. This role will also be key in creating and auditing processes within the clinical team.

About the Role:

  • Establish, implement, and manage clinical projects, collaborating with cross-functional groups, monitoring timelines and budgets, and adjusting activities as needed.
  • Develop core clinical documents, including protocols, case report forms, informed consent forms, and study agreements, ensuring thorough documentation for study initiation.
  • Identify, evaluate, and audit investigational sites for trial participation, providing training on protocol requirements and supporting data collection and reporting.
  • Support investigators in preparing and submitting required documentation to Institutional Review Boards (IRBs), ensuring compliance with reporting requirements and maintaining IRB approval throughout the study.
  • Manage the clinical publications strategy, serving as a subject matter expert (SME), and leading or participating in cross-functional teams.
Minimum Qualifications:
  • Bachelor's degree in Life Sciences, Masters or Doctoral degree preferred.
  • Eight or more years of clinical operations experience for CPM; with increasing levels of responsibility, in the Medical Device or CRO industry is required.
  • Minimum two years of clinical project management experience
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA/EU regulations and ICH Guidelines, ISO 14155, clinical research and data management method
Preferred Qualifications:
  • Therapeutic/Intervention experience in Urogynecology, GI, OB-GYN preferred
  • Experience with medical devices CER, PMS, PMCF, PSUR medical writing preferred
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 2023 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.

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