Job Posting Title Manager, Clinical 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. Quality **Clinical Quality **Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D; Quality CRM team located at a J&J; office in Spring House, PA; About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Learn more at note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. The Manager, Cross TA Clinical Risk Management, works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well
- being, or rights. Throughout the duration of the trial/program, this Manager executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness. Maintains CQP (Clinical Quality Plans)



in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews Communicates and facilitates risk updates to R&D; colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned). Highlight new potential systemic risk to RDQ CRM management. Develops and ensures a consistent interpretation of issues that require quality investigations Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D; management. In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self
- Identified, Inspection, Audit) Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams. Provides support for Investigator,



Sponsor-Monitor and third-party inspections including post inspection support Provides independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy. A minimum of a Bachelor's degree (scientific, medical, or related discipline) is required. A minimum of 8 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required. Proven strong GCP Quality and/or clinical trials experience is required. Flexibility to respond to changing business needs is required. Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and general business structures is required. Proficiency in Microsoft Office Applications is required. Experience with fundamentals of clinical trial risk management is preferred. Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred. Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred. Strong Project Planning/Management skills is preferred. Experience in managing escalations and CAPA support/advisement is preferred. Experience and/or proficiency with data analytics and/or data visualization tools (i.
Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred. Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred. Requires proficiency in speaking and writing English. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,

📌 Global Clinical Risk Manager (España)
🏢 Johnson & Johnson Innovation
📍 España