Clinical Safety Specialist

Company: Disability Solutions
Location: Danvers
Posted on: May 4, 2024

Job Description:

Abiomed, part of Johnson & Johnson's MedTech is recruiting for a Clinical Safety Specialist , located in Danvers, MA or Remote. Remote work options may be considered on a case-by-case basis and if approved by the Company. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at The Clinical Safety Specialist is responsible for implementing and executing clinical trial safety activities and responsibilities for the clinical research programs. Job Responsibilities: --- Management of safety related clinical trial activities for assigned studies including: o Ensure timely and accurate execution of all safety related processes (study-specific) per study Safety Management Plan (SMP) and applicable Charters o Conduct ongoing medical reviews of safety related events (e.g., AEs, DD/DMs) per study SMP o Manage safety related processes: o Develop, implementation and ongoing management of study-specific Safety Management Plan (SMP) and Case Report Forms (e.g., AE, DD/DM, and Adjudication CRFs) and Charters o Review of draft informed consent forms (templates and site specific) o Safety requests for and review of source documents o Issuing and resolving safety queries in the study database o Event reconciliation between EDC and Quality Assurance/Complaints o Manage activities related to study committees (CEC, DSMB/DMC, Independent Medical Monitor) or overseeing third party management of committee activities per study SMP and associated Charters o Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting. o Review applicable study reports and statistical outputs as needed o Other clinical trial safety activities as directed --- Support the review, implementation, and execution of standard operating procedures (SOPs) --- Contribute to the development and implementation of medical safety program initiatives, process improvements and sound safety practices

Keywords: Disability Solutions, Quincy , Clinical Safety Specialist, Healthcare , Danvers, Massachusetts