Job Title: Clinical Research Project Manager – Post-Market Medical Device Studies
Location: Remote
Duration: 12 Months

JOB DESCRIPTION:

We are seeking 2 experienced Clinical Research Project Managers to join our innovative team in the Post-Market Clinical Follow-Up (PMCF) space. Our projects focus on alternative data strategies such as healthcare provider (HCP) surveys, retrospective chart reviews, registries, and retrospective data analysis for peripheral vascular devices.
This is not a typical clinical trials role—our work involves operationalizing innovative data collection strategies to meet regulatory and business goals, delivering accurate, quality-driven, and timely results.
As a Clinical Research Project Manager, you will lead end-to-end PMCF projects that impact both regulatory compliance and patient outcomes. You will own project planning, execution, and delivery, while ensuring data integrity and cross-functional collaboration across diverse stakeholders.

· Project Oversight & Leadership: Lead planning and execution of PMCF studies (e.g., chart reviews, HCP surveys, registry studies). Ensure delivery on-time, on-budget, and with high quality.
· Study Design & Planning: Develop data collection plans, design scientifically robust protocols, case report forms, and survey tools. Align endpoints with regulatory and business objectives.
· Vendor & Site Management: Oversee vendor collaborations, manage site selection and initiation, and maintain HCP engagement.
· Data Integrity & Reporting: Ensure rigorous quality control, collaborate with statisticians and clinical evaluation teams, and prepare final study reports.
· Regulatory & Compliance: Ensure compliance with ISO 14155, EU MDR, GCP, HIPAA/GDPR, and corporate governance standards.