At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

We are seeking a Principal Clinical Research Specialist to serve as a Study Manager supporting Pelvic Health clinical studies across Europe including the UK France Belgium and Germany. This role offers the opportunity to lead and shape the execution of meaningful clinical research that directly impacts patient care. As a Study Manager you will take ownership of multi-site studies from startup through closeout working closely with investigators crossfunctional partners and external vendors to deliver highquality compliant clinical evidence in a dynamic global environment.

This is a remote position that will partner closely with the Pelvic Health clinical team based in Minneapolis MN. Travel up to 20% is expected to support site engagement and study execution across Europe.

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

• Lead the design planning and execution of registered and nonregistered Pelvic Health clinical studies including authorship of clinical protocols case report forms and related study documents
• Provide endtoend operational oversight of multisite clinical trials ensuring compliance with SOPs GCP and countryspecific regulations and supporting clinical trial budget development as needed
• Interpret and oversee clinical investigation data to support medical evidence generation regulatory submissions and new or expanded device applications
• Manage key operational components of clinical studies including clinical supply operations site and vendor selection and crossfunctional coordination with internal and external partners
• Serve as a clinical research representative within the assigned region building strong relationships with investigators customers and regulatory authorities while driving local evidence dissemination and incorporating regional feedback into study execution

Required Knowledge and Experience:

• Extensive experience managing multisite international clinical studies within the medical device or regulated healthcare industry with demonstrated Study Managerlevel accountability
• Strong working knowledge of ICHGCP ISO 14155 EU MDR UK clinical research requirements and applicable countryspecific regulations with handson application in study execution
• Prior experience authoring and reviewing clinical study documentation including protocols CRFs and clinical reports and interpreting clinical data to support evidence generation and regulatory needs
• Demonstrated ability to manage clinical trial operations including vendor and site oversight clinical supplies budgets and crossfunctional collaboration in a global environment
• Strong communication stakeholder management and organizational skills with the ability to work independently in a remote role

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here