Ph3Manager, Cross Therapeutic Area Clinical Risk Management /h3 pJohnson Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our RD Quality CRM team. /p h3The Responsibilities And The Impact YOU Will Have /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 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 risks 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 coordinates mock inspection 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 Requirements /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 is 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 Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred. /li liHealth Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred. /li liStrong Project Planning/Management skills is preferred. /li liExperience in managing escalations and CAPA support/advisement is preferred. /li liExperience and/or proficiency with data analytics and/or data visualization tools (i.e., 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% of travel, primarily domestic with some international travel. /li /ul h3Required Skills /h3 ul liBudget Management /li liClinical Research and Regulations /li liClinical Trials Operations /li liCompliance Management /li liCompliance Risk /li liContinuous Improvement /li liDeveloping Others /li liFact‑Based Decision Making /li liInclusive Leadership /li liLeadership /li liOperations Management /li liPerformance Measurement /li liQuality Control (QC) /li liQuality Management Systems (QMS) /li liQuality Standards /li liRisk Assessments /li liStandard Operating Procedure (SOP) /li liTactical Planning /li liTeam Management /li liVendor Selection /li /ul h3Preferred Skills /h3 ul liBudget Management /li liClinical Research and Regulations /li liClinical Trials Operations /li liCompliance Management /li liCompliance Risk /li liContinuous Improvement /li liDeveloping Others /li liFact‑Based Decision Making /li liInclusive Leadership /li liLeadership /li liOperations Management /li liPerformance Measurement /li liQuality Control (QC) /li liQuality Management Systems (QMS) /li liQuality Standards /li liRisk Assessments /li liStandard Operating Procedure (SOP) /li liTactical Planning /li liTeam Management /li liVendor Selection /li /ul h3Benefits Compensation /h3 pThe anticipated base pay range for this position in the Netherlands is €79,800.00 to €137,770.00 on an annual basis, which includes an 8% holiday allowance, plus additional attractive benefits. /p /p #J-18808-Ljbffr