Clinical Safety Specialist
Company: Disability Solutions
Location: Danvers
Posted on: May 4, 2024
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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, Brookline , Clinical Safety Specialist, Healthcare , Danvers, Massachusetts
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