Senior Clinical Research Progran Manaager

Medtronic is a global leader in healthcare technology with a mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to develop innovative medical technologies that improve the lives of 72+ million patients each year.

About the role

As a Senior Clinical Program Manager (CPM) in the Peripheral Vascular Health portfolio, you will lead the development and execution of the global clinical evidence strategy and roadmap for multiple medical device products. This role involves defining clinical evidence needs, identifying gaps, and implementing strategies to generate data supporting regulatory, clinical, and business objectives. You will collaborate with internal and external stakeholders, including key opinion leaders, to understand therapy and market needs while maintaining expertise in Medtronic technologies.

This position is based in Plymouth, MN, and requires a minimum of 4 days per week onsite to foster professional growth and cross-functional collaboration.

Responsibilities

• Plans and oversees clinical research programs from concept through completion.
• Develops and maintains detailed project plans, including timelines, budgets, resource allocations, decision logs, risks, and mitigations.
• Prepares program dashboards to communicate portfolio status, highlights, risks, and mitigations.
• Presents to and partners with clinical and medical science team members and leadership on portfolio health, successes, and areas of opportunity.
• Works cross-functionally with Clinical, Medical Science, Quality, Medical Safety, Regulatory Affairs, Marketing, Market Development, R&D, and regions (US and OUS) to ensure program execution aligns with business goals and regulatory requirements.
• Ensures clinical trials are conducted in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs.
• Identifies and leverages innovative real-world data and real-world evidence opportunities to fulfill evidence requirements, optimizing time and costs.
• Builds and maintains partnerships with key opinion leaders to understand clinical therapy and market needs.
• Coordinates clinical evidence strategies with cross-functions to ensure a robust Clinical Research Management System (CRMS) strategy.
• Serves as Core Team representative, providing clinical subject matter expertise (SME) and CRMS representation on technology development, product development, continued development, and remediation projects.
• Leverages competitive intelligence around clinical/regulatory pathways, indications, labeling, claims, and clinical evidence to inform and execute market-leading strategies.
• Determines the burden of evidence for products and partners with stakeholders to develop innovative clinical development plans for timely product launches, market access, and adoption.
• Provides input into clinical investigation documents (e.g., protocols, case report forms, informed consent forms, clinical study reports) to ensure alignment with business strategy.
• Leads document development and execution of studies as needed.
• Interprets and disseminates results of clinical investigations to support new device applications.
• Works with statistical teams on data analysis from internal and external databases.
• Leads cross-functional project teams and facilitates communication among team members, stakeholders, and external partners.
• Provides regular updates to senior management and cross-functional leaders on project status, risks, and issues.
• Ensures all clinical research activities comply with applicable regulatory requirements and ethical standards.
• Prepares and submits regulatory documents (e.g., protocols, informed consent forms, progress reports) and coordinates with regulatory authorities and ethics committees for approvals.
• Provides input and review for clinical evaluation documents (e.g., Clinical Evidence Plan, PMCF plan/report, Clinical Evaluation Report, risk management files, IFU development) to align with product MDR strategy.
• Oversees data collection, management, and analysis to ensure accuracy and integrity.
• Works with data management and biostatistics teams to develop data management and statistical analysis plans.
• Ensures timely and accurate reporting of study results.
• Drives the global publication and evidence dissemination strategy through collaboration with Medical Science, healthcare economics, global portfolio, and marketing functions.
• Performs financial budget modeling and scenario planning for evidence needs.
• Advocates for appropriate support and funding for high-priority projects.
• Develops and manages program budgets, including forecasting and tracking expenses.
• Ensures projects are completed within budget and on schedule while identifying and mitigating financial risks.
• Builds and maintains strong networks with internal and external stakeholders.
• Maintains a strong understanding of product knowledge, relevant anatomy, and accepted applications of Medtronic products.
• Provides clinical input to functions such as General Management, Global Strategy & Portfolio Management, Business Development & Licensing, R&D, and Marketing to facilitate decision-making.
• Critically evaluates due diligence information for inorganic opportunities.
• Assesses project issues and develops resolutions.
• Develops mechanisms for monitoring project progress and problem-solving.
• Understands the market and competitive space.
• Reviews marketing materials for clinical evidence claims.
• Provides scientific input for evidence generation, including sponsored research, ERPs, Scientific Services, Collaborative Research, and Alternative Data Source projects.

Requirements

• Bachelor’s degree with a minimum of 7 years of experience in clinical research or clinical strategy in the healthcare industry, or an advanced degree with a minimum of 5 years of experience in clinical research or clinical strategy in the healthcare industry.
• For Baccalaureate degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

Skills

• Nice to Have:
• Degree in engineering, life sciences, or a related medical/scientific field.
• Clinical research or clinical trials experience at Medtronic or within the medical device industry.
• Experience in clinical operations.
• Experience developing clinical strategies and study design.
• Experience in Peripheral or Endovenous therapies/products.
• Experience working on a global study team.
• Basic understanding of biostatistics and trial design.
• Research and Development (R&D) experience.
• Project/program management skills.
• Ability to apply standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.).
• Proficiency in MS Office applications (Excel, PowerPoint, Word, Project or similar scheduling software), project management techniques and tools, and web-based applications.
• PMP certification, Project Management Certification (preferably PMI), and/or Green Belt Certification.
• Ability to thrive in a dynamic environment and adapt to changing priorities.

Benefits

Medtronic offers a competitive salary and flexible benefits package.

U.S. work authorization sponsorship is offered exclusively for Principal-level roles and above. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.