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.

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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:

* 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

* Review of draft informed consent forms (templates and site specific)

* Safety requests for and review of source documents

* Issuing and resolving safety queries in the study database

* Event reconciliation between EDC and Quality Assurance/Complaints

* 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 or life sciences

* Minimum of 5 years experience implementing safety processes or clinical research experience including management of safety events (medical devices preferred)

* Experience managing or execution of processes for CEC and DSMB/DMC

* Experience in or knowledge of 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 4.19.2024. The Company may however extend this time-period, in which case the posting will remain available on 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 Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to:

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.