MDR-Clinical Research Project Manager

MDR-Clinical Research Project Manager
100% Remote
Duration: 12 Months+
Shift: 1st Shift (CST)

JOB DESCRIPTION
Clinical Research Project Manager
Location: Remote

Top 3 things the manager is looking for:
1. Demonstrated experience leading Clinical Research projects end-to-end.
2. Strong Project Management skills
3. Excellent communication, leadership, and problem-solving skills

Top 3 Tasks or Responsibilities in Product for this role:
1. Lead the planning, execution, and completion of Clinical Research projects and Post Market Clinical Follow-up (ProductF) projects and business needs for peripheral vascular devices, including data from retrospective chart reviews, HCP surveys, registries, and retrospective data analyses.
2. Own the data collection plan and ensure collaborative efforts to design scientifically robust data collection protocols tailored to peripheral vascular patient populations while ensuring study endpoints align with regulatory and/or business objectives. This includes implementation of data capture tools, ensuring alignment with study protocols and optimization of workflow efficiency for accurate and timely data collection.
3. Ensure rigorous quality control through data monitoring and query resolution for high-quality study results and develop the final study report.

Key Responsibilities

Project Oversight & Leadership

• Lead the planning, execution, and completion of Clinical Research projects and Post Market Clinical Follow-up (ProductF) projects and business needs for peripheral vascular devices, including data from retrospective chart reviews, HCP surveys, registries, and retrospective data analyses.

• 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, Clinical Investigations team, Biostatistics, Regulatory Affairs, Marketing, Sales, Device subject matter experts, etc., throughout the project lifecycle.

• Drive project outcomes through strong organizational leadership, including risk management, issue resolution, benefits tracking, and change control.

• Lead project team meetings and ensure clear documentation of decisions and action items.

• Provide timely study updates, and escalations as appropriate stakeholders including project teams and internal leadership.

• Stay current on industry best practices and methodologies in project management and clinical research.

Study Design & Planning

• Own the data collection plan and ensure collaborative efforts to design scientifically robust data collection protocols tailored to peripheral vascular patient populations.

• Work closely with across teams to ensure study endpoints align with regulatory and/or business objectives for peripheral vascular devices.

• Develop case report forms (CRFs) and/or clinical survey questionnaires to support desired data collection requirements for research studies.

• Collaborate with cross-functional teams and vendors to implement data capture tools, ensuring alignment with study protocols and optimization of workflow efficiency for accurate and timely data collection.

Vendor and Site Management

• Collaborate with external vendors for project execution based on the Product of work contracted.

• Oversee site identification, feasibility assessments, and selection processes.

• Lead site qualification, initiation, training, and activation for interventional vascular centers across diverse geographies.

• Monitor site/HCP enrollments and support site/HCP engagement throughout the study lifecycle.

• Ensure proper project close-out.

Data Integrity and Analysis & Reporting

• Ensure rigorous quality control through data monitoring and query resolution for high-quality study results.

• Collaborate with the Clinical Evaluation team, Clinical Investigations team, Biostatisticians, Regulatory, and other SMEs to support data interpretation, publications, and regulatory submissions as applicable.

• Prepare study reports.

Regulatory and Compliance Oversight

• 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.

Qualifications

Required:

• Bachelor s degree in life sciences, biomedical engineering, nursing, or related field (advanced degree preferred)

• 3+ years of demonstrated experience managing clinical research projects such as retrospective/observational studies, preferably in the medical device industry

• 3+ years of clinical project management experience in medical devices

• Experience with electronic data capture (EDC)

• 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

• Excellent communication, leadership, and problem-solving skills

Preferred:

• 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