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 be responsible for all aspects of planning, coordination, and execution of clinical projects mainly in support of indication expansion projects and investigator-initiated research at LABORIE in accordance with the relevant standards as well as LABORIE standard operating procedures. The Clinical Project Manager will also interface with KOLs to gather real-world data and be responsible for overseeing and managing all aspects of investigator-initiated clinical studies from conception to completion.
About the Role:
- Establishes, implements, and manages clinical projects including the following activities: project planning and clinical study design development; collaborating with cross functional groups with varied functional expertise; establishing and monitoring clinical timelines and budgets, anticipating schedule impacts and adjusting project team activities as required.
- Develops core clinical documents, including the clinical study protocol, case report forms, informed consent forms, clinical study agreements, investigator manuals, investigator files, and all other necessary documentation for study initiation.
- Identifies, evaluates and audits investigational sites to determine site qualification for participation in clinical trials. Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary.
- Supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs) for approval. Is aware of IRB reporting requirements, ensures maintenance of IRB approval throughout the duration of the study, and ensures compliance with national and international regulations.
Minimum Qualifications:
- Master's degree or equivalent experience required.
- Typically requires 8+ years of relevant work experience to develop the competence to demonstrate and fulfill the duties and responsibilities of the position.
- Experience with regulations and standards affecting the medical diagnostic industry.
- Experience with or exposure to Good Clinical Practices.
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.
#J-18808-Ljbffr
