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Principal Clinical Safety Specialist (Irvine, CA)

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Clinical
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19000EPF Requisition #
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Location:  Irvine, CA  

 

Careers That Change Lives

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

 

In this exciting role as a Principal Clinical Safety Specialist (Principal CSS) in the Medtronic Neurovascular business, 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 Principal 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.

 
Come for a job, stay for a career.
 
RTG

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

 

Within RTG, the BRAIN THERAPIES division offers an integrated portfolio of devices

and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

 
 
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.
  • 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:
  • Clinical Safety input into the baseline risk development (RMW’s, CRBA, Harms and Hazard Codes)
  • Contribute to CIP (Clinical Investigational Plan) ICF (Informed Consent Form), eCRF (Case Report Form), and CSR (Clinical Study Report) development
  • 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
  • Review safety data requiring escalation as per the Clinical Safety Management Plan
  • Develop safety training for internal sponsor personnel as well as participating site personnel
  • Act as a mentor/source to support staff
  • Interface with internal partners (Regulatory Affairs, Data Management, Complaint Handling), as needed
  • Other incidental duties, including occasional participation in internal or external audits, and travel, when required.
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 of 7 years of clinical/clinical research/clinical safety experience, or advanced degree with a minimum of 5 years of clinical/clinical research/clinical safety experience.

 

Nice to Have (Preferred Qualifications): 

  • M.D. Degree
  • 5 years of industry experience as a clinical safety specialist
  • 1+ years of clinical experience (patient care)
  • Experience in a global, matrix management structure
  • Experience at Medtronic or within the medical device industry
  • 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)

 
Ability to travel up to 10% domestic and international.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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