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Principal Clinical Research Specialist Neuromodulation (Brain Modulation)

Medtronic
Mansfield, MA 02048
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Principal Clinical Research Specialist Neuromodulation (Brain Modulation)

Location:

Fridley, Minnesota, United States

Requisition #:

220003IE

Post Date:

2 days ago


**Careers That Change Lives**


This is an exciting role as part of the Neuromodulation Operating Unit within the Neuroscience portfolio at Medtronic. The **Principal Clinical Research Specialist (CRS)** is responsible for the development and execution of clinical studies and for developing and overseeing clinical strategies for effectively assessing performance related to the ongoing evaluation of product safety and effectiveness following market release. You will lead study management duties and drive processes to meet the milestones of complex clinical studies/projects for assigned clinical programs to evaluate performance, safety, and effectiveness of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Assumes project management responsibilities for selected studies and site management activities as needed.


This role utilizes their broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and may be global in nature. This role works independently and under only general direction. The position provides work direction and strategic oversight of personnel supporting their trial.


**Neuromodulation Operating Unit**


Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients.Were committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures and deliver successful patient outcomes.


We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader thats why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion Diversity at MedtronicClick Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)


Location:Minneapolis, MN or remote within the U.S.


Ability to travel up to 25%


**A Day in the Life**


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


+ Oversees, designs, plans, and develops clinical evaluation research studies for products that are under Clinical Investigation.

+ Prepares and authors protocols and patient record forms.

+ Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.

+ Oversees and interpret results of clinical investigations in preparation for new device or consumer application.

+ Oversees and manages operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.

+ Serves as liaison between program management and planning, study team, and leadership

+ Provides work direction to a cross-functional team which includes site managers, monitoring, safety, stats, and others

+ Reviews status of projects and budgets; manages schedules and prepares status reports.

+ May be responsible for clinical supply operations, site and vendor selection.

+ People working within region/country may also have the responsibilities that include:

+ Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.

+ Builds and maintains optimal relationships and effective collaborations with various internal and external parties.

+ Drives local evidence dissemination awareness.


Other Responsibilities:


+ Collaborates closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates

+ Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.

+ Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation


**Must Have (Minimum Requirements):**


**To be considered for this role, the minimum requirements must be evident on your resume.**


+ Bachelors degree required with a minimum of **7** years of clinical research experience (i.e., in the development and execution of clinical studies) or advanced degree with a minimum of **5** years of clinical research experience (i.e., in the development and execution of clinical studies)


**Nice to Have (Preferred Qualifications):**


+ Degree in engineering, life sciences, or related medical/scientific field

+ Clinical Research experience at Medtronic or within a medical device industry

+ Experience developing clinical strategies and study design

+ Experience in Neuromodulation therapies/product

+ Experience working on a global study team

+ Basic understanding of biostatistics and trial design

+ Project/program management skills/experience

+ Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed

+ Experience in Research and Development (RD)

+ Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials

+ Proficient in MS Office applications: Excel, PowerPoint, Word, MS Project (or similar scheduling software), project management techniques and tools.

+ Expertise in both theoretical and practical aspects of project management

+ PMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification


**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It 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 team. Lets work together to address universal healthcare needs and improve patients lives. Help 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 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. (ADA-United States of America)


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.


**Learn more about our benefits at benefits.medtronic.com**
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2022-03-31 Expires: 2022-06-20
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Principal Clinical Research Specialist Neuromodulation (Brain Modulation)

Medtronic
Mansfield, MA 02048

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