Senior Clinical Research Program Manager - Neuromodulation (Rice Creek, MN) at Medtronic

Posted in General Business 4 days ago.

Type: Full-Time
Location: Minneapolis, Minnesota





Job Description:

Careers That Change Lives

In this exciting role as Senior Clinical Research Program Manager, you will be responsible for helping lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.

Neuromodulation

Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function, and improve lives for our patients. We're committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures, and deliver successful patient outcomes.

Location: Rice Creek, MN

Ability to Travel: up to 30%

A Day in the Life

The Sr. Clinical Research Program Manager is responsible for establishing and leading the global clinical evidence strategy for Neuromodulation Pain Therapies. This position has broad responsibility for owning and executing Spinal Cord Stimulation clinical research activities, including setting, and executing an evidence strategy, clinical care pathway evidence generation, evaluating physician-initiated research, and ensuring strategic alignment to business needs. Primarily, the program manager role will focus on evidence for Spinal Cord Stimulators and related Digital Health solutions. This position will also implement a real-world data and evidence strategy. The objective is to provide thought and people leadership, and to support the development of new frameworks and methods to drive the evolving real-world evidence methodology. This position closely collaborates with leading researchers at top healthcare institutions and regulatory agencies.

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


  • Develop and execute clinical program strategy

    • Drive clinical program strategies for new technology, new indication, regulatory and reimbursement approvals for Implantable Pain Therapies portfolio by designing and executing clinical studies

    • Responsible for clinical research projects being on-time and within budget.

    • Direct day-to-day activities for multiple work-streams with clear project plans, resourcing, status reporting and issue resolution

    • Oversee clinical advisory boards to guide clinical strategy

    • Lead the review of physician-initiated research proposals to assess alignment with strategy

    • Collaborate across functions including Clinical, Quality, Reimbursement & Health Economics Outcomes Research, Medical Safety and Medical Affairs, Marketing and Regulatory Affairs to ensure program execution to achieve business goals within regulatory requirements.

    • Represent Clinical function on product development core teams


  • Drive publication planning and evidence dissemination

    • Responsible for Implantable Pain Therapies publication planning and evidence dissemination strategy in collaboration with healthcare economics, global portfolio, and marketing functions

    • Prepare manuscripts and presentations on clinical studies and/or scientific reports

    • Partner with KOLs and review literature to identify unmet needs and define evidence gaps.

    • Develop clinical messaging and presentation materials for external audiences at conferences

    • Review and develop regulatory documents to ensure alignment with MDR strategy like Clinical Evidence Plan (CEP), PMCF plan, PMCF report, Clinical Evaluation Report (CER)


  • Digital Health tools for Neuromodulation clinical research

    • Lead the commissioning of Neuromodulation digital health tools for the collection of high-quality, clinical research data from implanted devices, peripherals, apps and wearables.

    • Develop program for Direct-to-patient recruitment of subjects for Neuromodulation clinical studies through internal Medtronic capabilities and external vendors

    • Partner with stakeholders in marketing, research & technology and clinical IT to leverage commercial digital health platforms to generate clinical evidence

    • Lead the activation of global study site for digital data collection

    • Oversee clinical ad boards for evidence generation from digital health systems


  • Real-world evidence (RWE) for Neuromodulation division

    • Fully harness real-world evidence to expand market access through competitive differentiation, strategic planning, claims development, therapy insights, study design, and care-pathway optimization.

    • Develop clinical data analytics function for RWE across Neuromodulation

    • Work with cross-functional stakeholders to identify and prioritize data science use cases that support key business needs.

    • Leverage real-world data in Medtronic registries and adopt alternative data sources (claims, electronic medical records) to generate evidence for Neuromodulation products


Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements must be evident on your resume.


  • Bachelor's degree required

  • Minimum of bachelor's degree with 7 years of clinical research strategy/program/project management OR advanced degree with a minimum of 5 years of relevant experience


Nice to Have (Preferred Qualifications):

  • Advanced degree in science or professional degree (DVM, Ph.D., PharmD, M.D.).

  • Demonstrated strong competency for strategy development, study design and analysis, including experience developing presentation materials, publications, and evidence dissemination tools.

  • Ability to analyze complex issues and significantly improve existing analytic methods.

  • Experience developing and maintaining project plans for multiple projects and provide weekly and/or monthly status reporting to upper management.

  • Proficiency in clinical research study processes and study design; Good Clinical Practices and regulatory standards

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

Ability to travel: up to 30%.

Additional Information


  • Posting Date: Sep 13, 2021
  • Travel: No





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