Clinical Research Manager

Medtronic•North Haven, MN

11h

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 The Clinical Research Manager, Core Surgical Innovations (CSI) reports to the Sr. Clinical Research Director, CSI. This position is responsible for leading a team of research coordinators and site leads responsible for supporting all global clinical research activities to generate clinical evidence in support of the business. The Clinical Research Leader is responsible for supporting the clinical strategy in alignment with the business, R&D and commercial strategies for the CSI Business Unit. The leader is also responsible for operationally driving the execution of pre-market and post-market clinical trials globally, including quality outcomes and results. The goal of these critical research programs is to develop the medical evidence necessary to demonstrate safety, efficacy, economic and quality of life outcomes for the performance of our products and therapies. Clinical research programs will support global regulatory approval, reimbursement coverage through comparative effectiveness evidence, therapy adoption and new indications. In addition, the individual will collaborate closely with CSI Clinical Program Managers and Clinical Strategy Managers to ensure ongoing alignment with over-arching evidence requirements, timelines and budget. Ideal candidate would work from our Boston, Lafayette or Minneapolis site. We will consider candidates from Europe, with a preference for Trevoux or Maastricht. In this exciting role as a Clinical Research Manager, your primary responsibility will be to lead a team responsible for preparing sites for data collection, relationship building with research coordinators, regulatory report writing, and data cleaning. In addition, the CRM will lead a number of key strategic initiatives in collaboration with Clinical Study Managers and Clinical Research Program Managers.

Requirements

Bachelor’s degree required
Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

Nice To Haves

Master’s degree plus 5+ years of related experience.

Responsibilities

Provides leadership for the conduct of clinical studies.
Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.
The result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.
Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.
Represents Medtronic from clinical research respective within the country / region and collects feedback from local customers and authorities.
Builds and maintains a strong network and close relationship with the various internal and external parties.
Leads execution for both local and global studies, manages clinical research projects over all the Medtronic products and therapies across the Core Surgical Innovations (CSI) BU.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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)