Specialist, Early Development Risk Management

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 https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Clinical Quality

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is currently seeking a Specialist, Early Development Risk Management to join our Clinical Research Management team located in Spring House, PA, Horsham, PA, La Jolla, CA, or Raritan, NJ.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Beerse, Belgium - Requisition Number: R-024958

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Specialist, Early Development Risk Management, reports to the Director, Early Development Clinical Risk Management.

The Specialist Early Development Risk Manager works with the trial teams to support and/or coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well – being, or rights.

Throughout the duration of the trial, the specialist supports the execution of data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials, compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

Key Responsibilities:

With supervision from the Director, ED Risk Management:
 

Risk Management


* Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.


* Supports regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound (SPECIALIST only), as assigned).


* Maintains CQP (Clinical Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews


* Communicates risk...