PpThe Director, Clinical Risk Management – Post Approval Delivery Unit – oversees the overall risk management of a Disease Area Stronghold (DAS) or development phase. The role collaborates with CRM Representatives to coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient rights, safety, or well‑being. The director ensures the execution of data‑driven, risk‑based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and a continued state of inspection readiness. /ph3Responsibilities /h3ulliEstablish goals and objectives for CRM Representatives. /liliConduct mid‑year and end‑of‑year reviews for CRM Representatives. /liliAssist in outlining and evaluating career development goals with CRM Representatives. /liliCoordinate workstreams to update processes for efficiency and maintain inspection readiness. /liliOrganise upskilling workshops for CRM Representative team development. /liliEnsure CRM representatives participate in pre‑study activities to identify and assess key risks in the clinical protocol or set‑up. /liliAdvise clinical and cross‑functional trial team members on effective mitigation strategies. /liliMaintain a consistent quality risk assessment process across the program. /liliProvide and lead strategic guidance on quality risk assessments, risk entries, and mitigation strategies. /liliApprove Clinical Quality Plans (CQP) risk monitoring information in the quality risk repository to facilitate regular progress reviews. /liliDrive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews. /liliCommunicate a strategic framework with business partners and quality management governance to keep them informed on key quality risks and mitigations. /liliFacilitate risk updates to RD Business Partners through regular review cycles via Quality Working Groups and Governance Fora. /liliWork with risk owners to develop effective risk mitigation plans at the trial level CQP. /liliHighlight new potential systemic risks to RDQ / CRM management. /liliConsult, Escalate, and assess compliance issues in consultation with the Head of Clinical Risk Management. /liliDevelop and enforce consistent interpretation of issues requiring quality investigations. /liliProvide guidance for significant quality issues (SQI) per corporate standards and escale SQI to senior RD management. /liliConduct initial serious breach evaluations of quality issues that may require reporting to Health Authorities. /liliAdvise on the development and implementation of Corrective and Preventative Action (CAPA) plans and effectiveness checks. /liliLead key inspection processes and inspection tools to maintain ongoing inspection readiness with trial teams. /liliDevelop inspection narratives, identify and prepare sites for inspection, and coordinate mock inspections with Regulatory Compliance teams. /liliProvide front and back room support for Sponsor‑Monitor inspections at JJ sites, including post‑inspection support. /liliProvide inspection support per contractual agreements for third‑party inspections (vendors, co‑development partners, and contract research organizations). /liliProvide remote support for investigative site inspections, including post‑inspection support. /liliMentor and coach others on inspection support and readiness. /liliProvide independent advice on research quality and compliance questions from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts. /liliSupport and lead the coordination of quality integration of acquired assets or companies, delivering robust documentation within the 90‑day plan. /liliLead general guidance to stakeholders and provide input into Quality Agreements with (Co‑)development partners. /liliFacilitate asset divestment requirements and integration as required. /li /ulh3Qualifications /h3ulliMinimum of a Bachelor’s degree in a scientific, medical, or related discipline. /liliMinimum of 10 years of experience in the healthcare industry (pharmaceutical, contract research organization, or healthcare/hospital system). /liliProven strong GCP Quality and/or clinical trials experience. /liliExcellent interpersonal, oral, and written communication skills. /liliFlexibility to respond to changing business needs. /liliDemonstrated ability to operate in a culturally diverse environment. /liliProficiency in Microsoft Office applications. /liliExperience with fundamentals of clinical trial risk management (preferred). /liliExperience working according to ICH guidelines (preferred). /liliKnowledge of GMP, GLP, and/or Good Pharmacovigilance Practice (preferred). /liliExperience with Health Authority inspections (FDA, EMA, and other inspectorates) (preferred). /liliStrong project planning and management skills (preferred). /liliExperience managing escalations and CAPA support/advisement (preferred). /liliProficiency with data analytics and/or visualization tools (e.g., Tableau, Spotfire) to provide insights for decision‑making (preferred). /liliExperience with Data Science and Digital Health, including Real World Evidence or Real World Disease (preferred). /liliProficiency in speaking and writing English. /liliUp to 10% travel, primarily domestic with some international travel. /li /ulh3Preferred Skills /h3ulliBudget Management /liliClinical Research and Regulations /liliClinical Trials Operations /liliCompliance Management /liliCompliance Risk /liliContinuous Improvement /liliDeveloping Others /liliFact‑Based Decision Making /liliInclusive Leadership /liliLeadership /liliOperations Management /liliPerformance Measurement /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliRisk Assessments /liliStandard Operating Procedure (SOP) /liliTactical Planning /liliVendor Selection /li /ul /p #J-18808-Ljbffr