Clinical Studies Support Coord III
MedtronicAbout the role
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
In this exciting role as the Clinical Studies Support Specialist III you will be responsible for managing projects assigned and will work with other stakeholders to achieve desired results. Your core responsibilities will be clinical study support and coordination. You will manage clinical study files and oversee the organization and distribution of clinical study documents, including binder preparation and shipment. You may act as a mentor to colleagues or may support the work of other professionals. The majority of time is spent supporting projects – from design to implementation - while adhering to policies, using knowledge and skills acquired through education and experience.
The Study & Scientific Solutions (S&SS) is a function within Medtronic Clinical & Regulatory Solutions (MCRS). S&SS is an internal service provider to all of Medtronic and assigns resources to assist Operating Units to execute on clinical trials and scientific projects when they have an increase in workload.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
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.
Responsibilities may include the following and other duties may be assigned.
Supports clinical studies by executing and maintaining one or more of the following areas.
Data coordination- actively participates in the development and testing of case report forms, study reports, and study databases based on protocol requirements.
Ensures timely and quality completion of data forms, verifies study data, and generates, manages and resolves data discrepancies.
May process compensation & identify and resolve compensation discrepancies.
Document coordination - creates and manages the clinical study files and oversees the organization and distribution of clinical study documents.
Assists with periodic audits of clinical study files for completeness and accuracy.
Must Have (Minimum Requirements)
High School Diploma or equivalent
Minimum of 4 years of relevant experience
Medtronic experience
Nice to have
Previous medical device industry experience
Experience in medical device clinical trials/clinical trial setting
Experience with Good Clinical Practice (GCP), regulatory and/or compliance guidelines for clinical trials
Experience with MS Office applications
Ability to balance multiple time-sensitive tasks in a constantly changing environment
Strong teamwork and collaboration skills
Good analytical and organizational skills
Exceptional attention to detail
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 job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
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