Careers that change lives
In this exciting role as the senior clinical research specialist-operations, you will be responsible for project management responsibilities for assigned studies to effectively assess performance related to the ongoing evaluation of product safety and effectiveness following market releaseThe senior cr-operations is accountable for maintaining operational strategies, business operations solutions, and lead process improvement activities to ensure consistent and efficient execution of post-market surveillance studies to include managing the timely completion of deliverables and coordination of activities with clinical affiliates in conformance with applicable federal regulatory requirements.
Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to marketThe post approval clinical surveillance team is recognized as an enterprise leader for cost effective global post market clinical surveillance methodologies and strategies to guide the generation of world class evidence and fulfill the medtronic missionCurrent evidence needs have created increased need to report clinical data and the group is experiencing significant growth.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every dayIt’s no accident — we work hard to cultivate a workforce that reflects our patients and partnersWe believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutionsTo learn more about inclusion & diversity at medtronic click here
Location: minneapolis, mn preferred; open for remote location within u.sAbility to travel 10-20%.
A day in the life
Responsibilities may include the following and other duties may be assigned.
Support creative strategies to address post-market clinical evidence needs while maintaining a high level of scientific rigor and ensuring cost effective solutions
Drive collaboration and development of high value post-market clinical operational strategies meet global regulatory, reimbursement, health care economics, and quality needs
Design, plan and manage operational activities to support post-market clinical evidence generation
Recognize and escalate performance trends to mitigate risk
Serve as clinical operational consultant to project teams
Must have (minimum requirements): to be considered for this role, the minimum requirements must be evident on your resume.
Bachelor’s degree required with a minimum of 4 years of clinical research experience or advanced degree with a minimum of 2 years of clinical research experience
Nice to have (preferred qualifications):
Project management or lean sigma certification
Master’s degree in life sciences/public health or related field
Clinical research experience at medtronic within the medical device industry
Proficient knowledge of medical terminology.
Working knowledge of quality system regulations (qsr 21 cfr 820), canadian medical device regulation (cmdr), eu medical device directive (eu mdd 93/42 eec), and iso 13485:2003 and 14155:2011
Strong knowledge of world health organization (who) good clinical practice (gcp) and international conference of harmonization (ich)
Demonstrated ability to cultivate relationships with co-workers in a global, cross-functional environment (easily builds rapport and trust, influence management skills, collaborative decision making).
About medtronic
Together, we can change healthcare worldwideAt medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterdayIt 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 teamLet’s work together to address universal healthcare needs and improve patients’ livesHelp us shape the future.
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.
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 jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsFor office roles: while performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer and communicate with peers and co-workersContact 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 10-20%.
A commitment to our employees lives at the core of our valuesWe recognize their contributionsThey share in the success they help to createWe offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Learn more about our benefits at benefits.medtronic.com
