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Job Requirements of MDR - Project Lead:
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Employment Type:
Contractor
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Location:
Minneapolis, MN (Onsite)
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MDR - Project Lead
Careers Integrated Resources Inc
Minneapolis, MN (Onsite)
Contractor
Job Title: MDR - Project Lead
Job Location: Minneapolis, MN (Remote)
Job Duration: 3 Months (possibility of extension)
Payrate: $50.00 - $60.00/ hr. on w2
Job Summary:
1. Project Oversight & Leadership:
Job Location: Minneapolis, MN (Remote)
Job Duration: 3 Months (possibility of extension)
Payrate: $50.00 - $60.00/ hr. on w2
Job Summary:
- The Clinical Research Project Manager (CPM) is responsible for leading Real-World Data (RWD) collection and Post-Market Clinical Follow-up (ProductF) 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.
1. Project Oversight & Leadership:
- Lead the planning, execution, and completion of RWD projects for ProductF 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 Product 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 Product 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.
- Contribute toward fit-for-purpose data collection strategies using electronic health records (EHRs), site-reported outcomes, and RWD databases.
- Collaborate on the design of scientifically robust protocols tailored to peripheral vascular patient populations.
- Offer feedback on study methodology and ensure rigorous quality control of analysis plans and study results.
- Work closely with Health Economics and Outcomes Research (HEOR) and Health Economics, Policy, and Reimbursement (HEPR) teams to support and review the design and implementation of retrospective studies.
- Ensure study endpoints align with regulatory and/or business objectives for peripheral vascular devices.
- Evaluate and recommend the use of new real-world data assets and analytics tools to enhance study quality and insights.
- Provide guidance on appropriate data sources such as PINC AI (Premier), CMS, and Optum.
- Ensure rigorous data monitoring, and query resolution for high-quality real-world evidence.
- Collaborate with the Clinical Evaluation team, Biostatisticians, HEOR, and other SMEs to support data interpretation, publications, and regulatory submissions.
- Prepare data reports.
- Ensure studies comply with global regulatory requirements including EU MDR, ISO 14155 framework, GCP, GDPR, and local data privacy laws.
- Maintain essential study documentation via assigned platforms like RAD, Veeva Vault.
- Ensure all projects adhere to corporate policies, regulatory requirements, and IT governance standards.
- 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.
- 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.
- PMP certification or equivalent.
- 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.
- Familiarity with safety and performance endpoints in peripheral vascular studies.
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