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Senior Clinical Research Specialist (Structural Heart & Aortic)

Medtronic
Santa Rosa, CA 95404
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Senior Clinical Research Specialist (Structural Heart & Aortic)

Location:

Santa Rosa, California, United States

Requisition #:

20000MZW

Post Date:

6 days ago


**Careers That Change Lives**


In this exciting role as a Senior Clinical Research Specialist in the Aortic business, now part of the new Structural Heart Aortic Operating Unit, you will have primary focus responsibility to lead study management duties 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.


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 Medtronic Click Here at https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html


Preferred location: Santa Rosa, CA, open for remote.


**A Day in the Life**


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


+ Oversees, designs, plans, and implements clinical studies consistent with global clinical evidence strategies

+ Determines study objective, strategy, scope and schedule in order to meet business needs

+ 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

+ Develops and maintains a high level of medical, technical and clinical expertise through relevant literature, scientific meetings, and interaction with various inside/outside experts

+ Collaborates closely with key opinion leaders

+ Partners with cross-functional project teams, e.g., RD, Regulatory Affairs, Marketing and Sales

+ Develops the Clinical Investigational Plan and supporting documents in consultation with the cross-functional project teams, investigators and the clinical team as appropriate for a clinical project

+ Reviews and approves required documents for study start, assures continued validity of such documents, takes actions for updates and/or replacements, and monitors site activation

+ Coordinates activities of associates (assigned clinical staff) and investigators to ensure compliance with CIP and overall clinical objectives

+ Participates in the selection of and manages CRO activities

+ Performs site visits to supervise and coordinate clinical studies

+ Evaluates clinical data/information, provides interim and final reports, convenes and directs investigator conferences to review findings and advise on direction

+ Serves as a medical / scientific consultant to marketing or research project teams and governmental regulatory agencies

+ Develops and manages budgets for assigned clinical studies and / or clinical research projects

+ Reports on progress and results of clinical investigations

+ Interprets, evaluates and analyzes clinical data, provides interim / final reports


**Must Have (Minimum Requirements):**


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


+ Bachelors degree required and a minimum of **4** years of clinical research experience, or advanced degree with **2** years of clinical research experience


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


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

+ Experience conducting/working on clinical trials and/or clinical studies and managing clinical trial data review

+ Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area

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

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

+ CCRA certification (Certified Clinical Research Association) or SOCRA certification

+ Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation and reporting

+ Experience with Clinical Operations and interfacing with CRO teams

+ Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; andweb-based applications

+ Excellent project management and organization skills

+ Technical writing experience

+ Global perspective


**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)


Travel up to 20%.


**Check out benefits.medtronic.com**


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 here at https://www3.benefitsolver.com/benefits/BenefitSolverView .


This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here .


Salary Min: $99,200


Salary Max: $148,800
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: 2021-01-12 Expires: 2021-02-15
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Senior Clinical Research Specialist (Structural Heart & Aortic)

Medtronic
Santa Rosa, CA 95404

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