Clinical Research Spec

Job description

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 DSM Clinical Safety Specialist will partner with various colleagues across Medtronic (e.g., other members of the DSM Clinical Safety team, other DSM 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. Position Responsibilities may include but are not limited to: 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 site...