Our mid-sized medical device client is adding a Senior Clinical Evidence Project Manager. The 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 companies 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 Clinical Team activities at the project level by meeting company and regulatory requirements according to time, quality/scope, and budget constraints.

Your role with the company:

• 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.

Desired Profile:

• Master's degree or equivalent experience 
• 8+ years of clinical research at a medical device company or CRO industry 
• Experience providing scientific leadership in study design and protocol development 
• Experience developing and implementing operational strategies for approval and execution of Investigator-initiated research
• Experience with global regulations, ideally EU MDR, and urology experience preferred.