Senior Clinical Research Manager - Onsite

Medtronic•Minneapolis, MN

3d•Onsite

About The Position

At Medtronic, a leader in medical technology and healthcare solutions, you can build a lifelong career of exploration and innovation while helping to champion healthcare access and equity. The Neuroscience portfolio, specifically the ENT operating unit, focuses on improving the lives of people with neurological disorders, spine conditions, and chronic pain by developing innovative technologies and therapies. This role is integral to the CRMS Leadership Team, reporting to the Vice President of Clinical Research & Medical Science (CRMS). The team works with a minimum of 4 days a week onsite to foster professional growth and cross-functional collaboration. Medtronic is committed to empowering employees and supporting their growth through training, mentorship, and guidance.

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