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Clinical Research Project Manager

Green Key Resources

Saint Paul, Illinois, United States

Saint Paul, Illinois, United States

Über

Get AI-powered advice on this job and more exclusive features. Demonstrated experience with working in or leading projects relying on Real-World Data (RWD) Sources from Electronic Health Records (EHR), and payor datasets e.g. CMS, PINC AI (Premier), Optum, and healthcare databases. Proven experience managing the execution Clinical Research data generation projects. About the Role The Clinical Research Project Manager (CPM) is responsible for leading Real-World Data (RWD) collection and Post-Market Clinical Follow-up (PMCF) initiatives for medical devices used in peripheral vascular interventions. This role is critical in generating Real-World Evidence (RWE) to support the safety, performance, and long-term clinical value of our vascular device portfolio. This role ensures the successful planning, execution, and delivery of projects in compliance with regulatory (EU MDR, ISO 14155 framework), and corporate requirements, in alignment with business goals. Responsibilities Lead the planning, execution, and completion of RWD projects for PMCF and business needs for peripheral vascular devices, with a focus on Electronic Health Records (EHR), and payor datasets. Manage core project constraints ensuring projects are delivered on time, within scope and budget targets and with the desired quality. Develop comprehensive project plans for successful project completion. Ensure cross-functional stakeholder alignment including but not limited to the EU MDR Clinical Evaluation team, Health Economics and Outcomes Research (HEOR), Biostatistics, Medical Science, Quality, Medical Safety, Regulatory Affairs, Marketing, throughout the project lifecycle. Collaborate with external vendors for project execution based on the scope of work contracted. Drive project outcomes through strong organizational leadership, including risk management, issue resolution, benefits tracking, and change control. Provide timely study updates, and escalations as appropriate to project teams and internal leadership. Stay current on industry best practices and methodologies in project management and clinical research. Qualifications Bachelor’s degree in life sciences, biomedical engineering, nursing, or related field (advanced degree preferred). 3+ years of experience managing clinical research or RWD projects, preferably in the medical device industry. 3+ years of clinical project management experience, including observational/RWD studies in medical devices. Experience with electronic data capture (EDC) and RWD platforms. Demonstrated experience with retrospective, non-interventional study design and execution. Knowledge of regulatory and ethical standards including ISO 14155, EU MDR, GCP, and HIPAA/GDPR. Proven ability to lead cross-functional teams and manage external vendors. Familiarity with secondary data sources such as CMS, PINC AI (Premier), Optum, and healthcare databases. Excellent communication, leadership, and problem-solving skills. Required Skills Specific experience in vascular or cardiovascular clinical studies, ideally with stents, balloons, atherectomy, or thrombectomy devices. Experience working with peripheral vascular surgeons, interventional radiologists, or interventional cardiologists. Familiarity with safety and performance endpoints in peripheral vascular studies. PMP certification or equivalent. Pay range and compensation package 100% remote 12 month W2 contract. Equal Opportunity Statement We are committed to diversity and inclusivity. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Project Management and Research Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Green Key Resources by 2x Inferred from the description for this job
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Saint Paul, Illinois, United States

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English

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