Sr Prin Clinical Research Specialist- Post Market Surveillance and Evidence

Senior Principal Clinical Research Specialist Post Market Surveillance And Evidence

The Senior Principal Clinical Research Specialist Post Market Surveillance and Evidence provides enterprise leadership in the strategic application of real world data (RWD) to support regulatory and post market clinical evidence strategies across Medtronic. This role serves as a recognized subject matter expert and provides strategic consultation to operating units and corporate clinical teams on the appropriate use of RWD to address clinical and regulatory questions and strengthen evidence strategies across the product lifecycle. The role functions in a strategic advisory capacity, helping teams understand how to identify and leverage different RWD sets for regulatory purposes, evaluate potential RWE approaches, assess available data sources, and identify opportunities where real world evidence may complement traditional clinical evidence. The position partners closely with Regulatory Affairs, Health Economics and Outcomes Research (HEOR), the PACS therapy teams, and operating unit clinical research teams to support evidence planning and regulatory engagement strategies while respecting the distinct roles and responsibilities of these functions. This role helps connect existing expertise across clinical, regulatory, and HEOR teams, supporting coordinated evaluation of RWE opportunities and promoting transparency, shared learning, and consistent approaches to the appropriate use of real world data across Medtronic.

Responsibilities may include the following and other duties may be assigned.

Guidance on Real World Evidence for Regulatory and Post Market Clinical Strategy

• Provide enterprise-level strategic guidance on the use of real-world data and real-world evidence to support regulatory and post market clinical evidence strategies across Medtronic.
• Provide strategic consultation to operating units and corporate clinical teams on evaluating real world data sources and determining appropriate applications of real-world evidence to address clinical and regulatory questions.
• Partners with PACS therapy teams, Regulatory Affairs leadership, HEOR leadership, and operating unit clinical teams to evaluate opportunities where real world data and real-world evidence may address regulatory questions or complement traditional clinical trial evidence.
• Guide operating unit clinical research teams in the strategic integration of real-world data into regulatory and post market clinical evidence plans across the product lifecycle.
• Identify and advance scalable real-world evidence use cases that support regulatory decision-making and post market clinical evidence generation across multiple operating units.
• Provide strategic input on clinical real world evidence study concepts, including registry-based studies, observational research, and post market evidence generation strategies.
• Advise teams on the appropriateness of real-world data approaches versus traditional clinical study designs to ensure regulatory evidence requirements and clinical questions are adequately addressed.
• Collaborate with Regulatory Affairs and HEOR to evaluate potential real-world evidence approaches while respecting functional ownership of regulatory and health economics strategies.

Strategy Assessment and Advisory

• Serve as an enterprise subject matter expert providing strategic consultation to operating units and corporate teams on real world data sources, data platforms, and methodological approaches for clinical and regulatory evidence generation.
• Evaluate and provide recommendations on operating unit real world data strategies to ensure alignment with regulatory expectations and clinical evidence needs.
• Provide consultative support to operating units and cross-functional teams to evaluate potential real world data approaches while aligning with clinical, regulatory, and HEOR evidence planning.

External Data Vendors and Partnerships

• Partner with HEOR, Regulatory, and operating unit teams to identify and strategically assess external real world data sources, vendors, and platforms that may support regulatory and post market clinical evidence generation.
• Collaborate to evaluate vendor capabilities, data quality, and suitability of data assets for regulatory and clinical evidence use cases.
• Advise operating units on external real world data partnerships supporting non-HEOR evidence generation initiatives.
• Support internal stakeholders in vendor evaluation, relationship development, and contracting considerations related to external real world data sources.

Cross Functional Leadership

• Partner closely with HEOR, Regulatory Affairs, and clinical research leadership to align approaches to evaluating and applying real world data while supporting each function's respective evidence planning responsibilities.
• Facilitate cross-functional collaboration across operating units to promote consistent application of real-world data and real-world evidence best practices.
• Serve as a strategic advisor to teams exploring clinical real-world evidence approaches for regulatory and post market evidence generation.

Education and Capability Development

• Co-lead enterprise education initiatives to strengthen internal understanding of real world data and real-world evidence methodologies and regulatory considerations.
• Co-develop and deliver training for operating units and corporate teams on evaluating, selecting, and applying real world data.
• Co-develop internal guidance, best practices, and use cases to promote consistent and effective use of real-world evidence across Medtronic.
• In collaboration with HEOR and Regulatory leaders, support clinical research teams in assessing potential real world data applications, identifying appropriate data sources, and determining whether available datasets can adequately address clinical and regulatory questions needed to support regulatory submissions.

External Landscape Monitoring

• Monitor evolving regulatory guidance and expectations related to real world data and real-world evidence.
• Translate emerging regulatory developments and industry best practices into strategic recommendations for internal stakeholders.

Must Have: Minimum Requirements

• Bachelor's degree required.
• Minimum of 10 years of relevant experience, or an advanced degree with a minimum of 8 years of relevant experience.

Nice to Have

• Advanced degree in epidemiology, public health, biostatistics, clinical research, or a related field, such as PhD, DrPH, PharmD, MD, or MPH.
• Bachelor's degree in epidemiology, public health, biostatistics, clinical research, or a related discipline.
• 5+ years of experience in clinical research, epidemiology, or real-world evidence generation.
• Experience in the medical device industry.
• Experience designing, supporting, or executing real-world evidence studies, including registry-based studies, observational studies, or post-market evidence generation initiatives.
• Experience working with real-world data sources and vendors to evaluate data capability, quality, and reliability.
• Experience leveraging registry data in regulatory submissions or post-market evidence strategies.
• Experience applying real-world data to support clinical or regulatory evidence strategies.
• Strong understanding of observational research methods and real-world data sources, including registries, claims databases, and electronic health records.
• Familiarity with regulatory frameworks and guidance related to real-world data and real-world evidence.
• Experience supporting post-market clinical evidence strategies or post-approval study planning.
• Experience collaborating with cross-functional teams, including HEOR, Regulatory Affairs, and Clinical Research, to translate evolving regulatory guidance into evidence planning approaches.
• Experience supporting regulatory interactions or submissions involving real-world evidence.
• Experience contributing to internal guidance, frameworks, or best practices for the use of real-world data in clinical and regulatory evidence generation.
• Experience participating in external collaborations such as MDIC or NEST.
• Strong communication, collaboration, and stakeholder engagement skills.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. 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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic