Clinical Safety Specialist

Medtronic • Minneapolis, MN

8h • Remote

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Clinical Safety Specialist is responsible for safety and potential complaint data throughout the clinical study to ensure compliance with respect to the reporting of clinical study safety and potential complaint data to meet regulatory requirements. The MCRS Clinical Safety Specialist will partner with various colleagues across Medtronic (e.g., other members of the MCRS Clinical Safety team, other MCRS functions, Regulatory Affairs, Clinical teams in the Operating Units) to manage adverse event, death, and device deficiency reporting in compliance with applicable regulatory standards and Medtronic internal requirements. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects. Responsibilities may include the following and other duties may be assigned.

Requirements

• Bachelor’s degree
• 2+ yrs safety experience
• Previous Medtronic experience
• Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• Fluent with medical terminology

Nice To Haves

• Good written, oral, and interpersonal communication skills including knowledge of medical terminology.
• Proficient with MS Office products, word processing, spreadsheets, etc.
• High attention to detail and accuracy and ability to manage multiple tasks.
• Good prioritization and organizational skills.
• Excellent problem solving skills
• Flexible and dependable.
• Works effectively on cross-functional teams.
• RN, PA or allied health professional including Biomedical Engineer, Biomedical Scientist, will work on Cardiac device trials Coordinator

Responsibilities

• Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
• Review non-AE Case Report Forms to detect potential complaint and potential unreported AEs
• Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP)
• Ensure consistency in the assessment of clinical safety events
• Work with Regulatory Affairs and the Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs) and potential complaints
• Ensure appropriate distribution and notification of SAEs and U[S]ADEs to appropriate personnel, partners, and investigational sites per CIP
• Act as liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites)
• Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies
• Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, and other documents as required
• Collaborate with Data Management and other departments on the development of case report forms, study specific safety reports, and other study specific forms
• Assist with the writing of safety sections of CIPs and may present Clinical Safety requirements at investigator meetings
• Support study audit for Safety-specific topics
• Facilitate Clinical Event Committee (CEC) work (author CEC charter, review source documents, ensure all CEC events are adjudicated by CEC)
• Support database snapshot activities (e.g., meet with study team, review timelines, perform reconciliation and data cleaning activities to be audit & snapshot ready)
• Prepare, attend and/or lead Safety Trending meetings
• Perform other Clinical Safety tasks as assigned

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level