TOP 3 MUST-HAVE SKILLS

1. Demonstrated experience leading clinical research projects end-to-end with hands-on RWD—including EHR and payor databases (CMS, PINC AI, Optum, etc.).
2. Outstanding project management ability in medical device clinical research.
3. Excellent communication, leadership, and problem-solving skills.

ABOUT THE ROLE

Seeking an experienced Clinical Research Project Manager to lead and deliver clinical research projects—including Post Market Clinical Follow-up (PMCF)—focused on peripheral vascular devices. Candidates must have substantial and hands-on experience with Real-World Data (RWD) from sources such as Electronic Health Records (EHR) and major payor databases (CMS, PINC AI, Optum, etc.).

KEY RESPONSIBILITIES

· Lead planning, execution, and completion of clinical research and PMCF projects for peripheral vascular devices, including retrospective chart reviews, health care provider surveys, registries, and data analyses.
· Own the data collection plan, design robust protocols, and ensure alignment with regulatory/business objectives for peripheral vascular patient populations.
· Develop case report forms (CRFs), clinical survey questionnaires, and oversee the implementation of data capture tools and workflow optimization.
· Oversee project constraints—delivering on time, within scope/budget, and at desired quality; manage risk, issue resolution, change control, and benefits tracking.
· Ensure rigorous monitoring and query resolution for high-quality study results; prepare study reports in collaboration with cross-functional teams.
· Coordinate stakeholders, including regulatory, biostatistics, marketing, device experts, and vendors throughout the project lifecycle.
· Maintain compliance with EU MDR, ISO 14155, GCP, GDPR, and local privacy laws. Manage essential documentation via platforms like RAD and Veeva Vault.
· Support site/vendor management, including feasibility assessments, site selection, qualification, initiation, monitoring, and close-out.