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Senior Clinical Research Specialist - Patient Monitoring

Medtronic
MN
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Senior Clinical Research Specialist - Patient Monitoring

Location:

Minnesota, United States

Requisition #:

2100040O

Post Date:

Mar 01, 2021


**Careers That Change Lives**


In this exciting role as aSr. Clinical Research Specialist (CRS)you will have primary focus responsibility to workclosely with Medical and Clinical Affairs leadership, Research Development, and Product Marketing and Market Development personnel in the development and execution of clinical studies for the Patient Monitoring and Respiratory Interventions Operational Unit in the MEDSURG portfolio.


Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.


To learn more about Inclusion Diversity at MedtronicClick Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)


**MEDSURG**


The MEDSURG portfolio strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.


Within MEDSURG, Patient Monitoring and Respiratory Interventions offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.


**Preferred Location: Boulder, CO; open for remote**


Ability to travel 10-25%


**A Day in the Life**


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


+ Oversees, designs, plans and develops clinical research studies. May be involved in early study development including statistical design of the trial.

+ 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.

+ Assists in Overseeing and interpreting results of clinical investigations in preparation for new drug device or consumer application.

+ Oversees and resolves 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.

+ Oversees clinical study operations, including safety, monitoring, data management, and site and vendor selection.

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

+ Escalates any study issues quickly to leadership and ensures study milestones are met.

+ Maintains understanding of regulatory requirements across multiple regions; serves as resource for clinical strategy personnel.

+ May represent Clinical Affairs team on certain product core teams providing SME support with clinical requirements in accordance with SOPs and regulations.


Other Responsibilities:


+ Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and management.

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

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

+ Develops mechanisms for monitoring project progress and for intervention and problem solving

+ Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity.

+ Organizational Impact: May be responsible for entire projects or processes within job area.

+ Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

+ Makes improvements of processes, systems or products to enhance performance of the job area.

+ Analysis provided is in-depth in nature and often provides recommendations on process improvements.

+ Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.


**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 **4** years of clinical research experience or advanced degree with a minimum of **2** years of clinical research experience


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

+ **Experience managing multiple clinical research sites with proven results in study execution**

+ **Experience working on a global study team**

+ **Experience in managing clinical trial data review**

+ **Basic understanding of biostatistics and trial design**


**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: 2021-02-18 Expires: 2021-05-10
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Senior Clinical Research Specialist - Patient Monitoring

Medtronic
MN

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