Senior Clinical Research Manager - Onsite

MedtronicLafayette, CO
Onsite

About The Position

At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. Our ENT operating unit provides innovative technologies for sinus, otology, neurotology, head & neck, skull base, and airway care. With advanced instruments, image-guided systems, and implants, we enhance precision, safety, and efficiency, supporting clinicians with education and clinical guidance to improve patient outcomes. Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to be part of technologies rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Reporting to the Vice President of Clinical Research & Medical Science (CRMS), you will lead and manage a high-performing, experienced Clinical Research team for the Ear, Nose & Throat (ENT) Operating Unit. This is an integral role on the VP’s CRMS Leadership Team, joining fellow leaders in Clinical Evaluation Writing, Medical Science strategy and program management, and Medical Affairs directors. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

  • Requires a Baccalaureate degree
  • Minimum of 7 years of relevant experience with 5+ years of managerial experience, or an advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.

Nice To Haves

  • Experience in clinical evidence strategy design and execution for new products, post market clinical follow up requirements, or adoption of existing products in US and/or international markets, preferably with drug/device combination products
  • Experience in clinical study regulation and compliance (e.g., ISO 14155, FDA GCP, ICH GCP, and EU MDR), Ethics, and Competent Authority Submissions
  • Experience or exposure to Investigator-Initiated Study program oversight, including protocol/budget review and engaging with Key Opinion Leaders and study investigators
  • Experience in vendor selection and management, Electronic Data Capture systems management, and other clinical operations tools
  • Knowledge of alternative evidence generation approaches other than traditional clinical trials, such as registries, claims data, or clinical surveys.

Responsibilities

  • Working cross-functionally to conduct gap analyses in clinical evidence and recommending strategies in line with business goals
  • Providing leadership for the conduct of clinical research for product approval, post-market clinical follow-up, and market adoption or development
  • Ensuring research plans are scientifically valid, meeting regulatory requirements, and are conducted within ethical guidelines
  • Ensuring audit readiness and participating in related activities, e.g., serving as a subject matter expert
  • Setting and communicating strategy, direction, priorities, and goals in partnership with the CRMS Leadership Team
  • Serving as the ENT Clinical Research representative for enterprise councils and communities of practice
  • Creating and maintaining a culture of ownership and accountability
  • Managing performance, developing talent, and fostering engagement and inclusion through 1:1s, feedback, coaching, and delegation
  • Setting and maintaining the budget and resourcing for the clinical research program and team
  • Advancing ways of working and operational efficiency, including the use of AI-enabled tools
  • Communicating business and operational developments up, down, and across
  • Preparing reports and presentations for internal and external stakeholders for projects and budgets, integrating information from multiple sources

Benefits

  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
  • Incentive plans
  • 401(k) plan plus employer contribution and match
  • Short-term disability
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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