Job Description

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 Senior Clinical Evidence Project Manager will be responsible for the strategic management and oversight of all aspects of the Clinical Trial Team activities for assigned projects in accordance with the relevant standards as well as Laborie standard operating procedures. The Senior Clinical Evidence Project Manager, in collaboration with Clinical Program Managers and senior leadership, is accountable for achieving successful delivery of Laborie Clinical Team activities at the project level by meeting company and regulatory requirements according to time, quality/scope, and budget constraints.

About the Role:

• Lead and manage the Investigator-Initiated Research (IIR) program, ensuring alignment with scientific, regulatory, and business objectives.
• Serve as the primary liaison for investigators, internal stakeholders, and cross-functional teams throughout the IIR lifecycle.
• Develop and implement operational strategies for efficient review, approval, and execution of IIR proposals and studies.
• Provide scientific leadership in study design, protocol development, and review of study-related documents to ensure methodological rigor.
• Collaborate with internal and external experts to design robust clinical and real-world studies, including endpoints, statistical plans, and feasibility assessments.
• Ensure compliance with regulatory standards (e.g., CGP, ICH), company policies, and SOPs across all IIR activities.
• Monitor program performance and quality metrics, ensuring timely progress and adherence to compliance frameworks.
• Drive real-world evidence generation, including identifying data sources, selecting analytic methods, and collaborating with data vendors and academic partners.
• Contribute to clinical and data strategy for product development, including support for new product launches and portfolio expansion.
• Lead cross-functional initiatives and process improvements, presenting updates to stakeholders and managing additional projects as needed.

Minimum Qualifications:

• Master's degree or equivalent experience required with increasing levels of responsibility in Medical Device or CRO industry.
• Typically requires 8+ years of relevant work experience to develop the competence to demonstrate and fulfill the duties and responsibilities of the position.
• Knowledge of GCP, ICH guidelines, ISO14155, and FDA and EU MDR regulations required.

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 2024 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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Job Tags

Full time, Work experience placement, Flexible hours,

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