PpJohnson Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join the RD Quality CRM team located at an office in Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; and Basel, Switzerland. /p pThe 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 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 programs, comply with regulatory requirements and internal procedures, and maintain a continued state of inspection readiness. /p h3Key Responsibilities /h3 ul liActively 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. /li liLeads 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, as assigned). /li liMaintains CQP (Clinical Quality Plans) in the quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations. /li liIndependently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews. /li liCommunicates and facilitates risk updates to RD colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned). /li liHighlights new potential systemic risk to RDQ CRM management. /li liDevelops and ensures a consistent interpretation of issues that require quality investigations. /li liProvides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior RD management. /li liIn 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). /li liDrives 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 coordinate mock inspections in collaboration with Regulatory Compliance teams. /li liProvides support for Investigator, Sponsor‑Monitor and third‑party inspections, including post‑inspection support. /li liProvides 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. /li /ul h3Qualifications /h3 ul liA minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required. /li liA minimum of 8 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required. /li liProven strong GCP Quality and/or clinical trials experience is required. /li liExcellent interpersonal, oral, and written communication skills to effectively collaborate in a cross‑functional team environment are required. /li liFlexibility to respond to changing business needs is required. /li liDemonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required. /li liProficiency in Microsoft Office Applications is required. /li liExperience with fundamentals of clinical trial risk management is preferred. /li liExperience working to ICH guidelines is preferred. /li liKnowledge of GMP, GLP, and/or GPvP is preferred. /li liHealth Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred. /li liStrong Project Planning/Management skills are preferred. /li liExperience in managing escalations and CAPA support/advisement is preferred. /li liExperience with data analytics and/or data visualization tools (e.g., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision‑making is preferred. /li liExperience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred. /li liRequires proficiency in speaking and writing English. /li liUp to 10% travel, primarily domestic with some international travel. /li /ul h3Benefits /h3 pIn addition to base pay, we offer an annual bonus with set target (% of pay) depending on pay grade / location, vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees – and in some locations eligible dependents – can participate in several insurance plans. /p pThis is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. /p pJohnson Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. /p pJohnson Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via /p /p #J-18808-Ljbffr