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Senior Clinical Trial Safety Specialist - Neurovascular

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Clinical
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210006KP Requisition #
Careers That Change Lives
In this exciting role as a Senior Clinical Safety Specialist (Senior CSS) in the Medtronic Neurovascular Operating Unit, you will have primary focus responsibility to provide functional expertise, leadership, support, and assistance to management and cross-functional teams to achieve business goals and objectives. The Senior CSS independently supports clinical safety deliverables across the entire product lifecycle from baseline risk management to proactive planning and effective execution of clinical trial safety strategy to submission of clinical trial data to regulatory authorities. You will partner with cross functional teams to ensure effective compliance to quality standards with regards to clinical safety and compliance to procedures of neurovascular product portfolio.

This is a unique opportunity to join a neurovascular product development group focused on developing solutions for patients suffering from neurovascular disease. The candidate will join a fast-paced, dynamic team and the individual who fills this position will play a pivotal role in the development of new therapies and devices from concept through to commercialization.

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.  To learn more about Inclusion & Diversity at Medtronic  Click Here

This is a remote based role so the candidate can live anywhere within the U.S.  Preferred location: Irvine, CA

Travel up to 15% (domestic and international).

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.
  • 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 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.
  • 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.
  • Clinical Safety input into the baseline risk development (RMW’s, CRBA, Harms and Hazard Codes)
  • Development of Clinical Safety Management Plans and be responsible for its training and execution
  • CEC charter development and effective execution including training of CEC members
  • Perform sponsor assessments of safety events and timely Potential Complaint triage.
  • Meet Global Safety Reporting Requirements including Periodic Safety Reports.
  • Lead Safety data cleaning of study database
  • Contribute to Clinical Study Reports, Annual Progress Report’s.
  • Write Safety Narratives
  • Contribute to safety data trending and analysis
  • Contribute to DSMB activities and other cross functional clinical safety deliverables
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume
  • Bachelor’s degree and a minimum 4 years of experience in Clinical Safety (i.e., in clinical trials safety), or advanced degree with a minimum of 2 years of experience in Clinical Safety (i.e., in clinical trials safety)

Nice to Have (Preferred Qualifications):

  • M.D. Degree, RN, PharmD, Pharmacy
  • 5+ years of experience as a Clinical Safety Specialist at Medtronic or within the medical device industry
  • Experience in a global, matrix management structure
  • Experience in IDE/Class III medical device clinical trials
  • Knowledge of GCP, HIPAA, ISO 14155, ISO 14971, 21 CFR 803 and other Global Safety Regulatory Requirements
  • Working knowledge of Clinical and Safety Database
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.

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. Let’s 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 15% (domestic and international).

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

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