Clinical Safety Specialist - Johnson and Johnson
Danvers, MA 01923
About the Job
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.
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• Bachelor's Degree required; preferably in nursing. healthcare or life sciences
• Minimum of 5 years experience implementing safety processes or clinical research experience including management of safety events (medical devices preferred)
• Must have clinical research experience
• Experience managing and execution of processes for CEC and DSMB/DMC preferred
• Experience with complaint handling, quality & regulatory processes preferred
• Strong interpersonal skills and well-developed written and oral communication skills
• Effective analytical and problem-solving skills
• Proficiency in guidelines, standards and regulations that are applicable to medical devices and medical device clinical trials, including 21CFR803, 21CFR812, MDCG 2020-10/1, , ISO 14155, EU MDR 2017, and country-specific regulatory requirements
• Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project) and clinical trial databases (e.g., Medidata Rave, Argus)
This job posting is anticipated to close on 5.29.2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $145,000.
The pay range is the anticipated pay range for the position to which you have applied, and that such factors, including but not limited to, internal equity and experience will be considered for any offer. Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.