The 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.
Responsibilities
* Establish goals and objectives for CRM Representatives.
* Conduct mid‑year and end‑of‑year reviews for CRM Representatives.
* Assist in outlining and evaluating career development goals with CRM Representatives.
* Coordinate workstreams to update processes for efficiency and maintain inspection readiness.
* Organise upskilling workshops for CRM Representative team development.
* Ensure CRM representatives participate in pre‑study activities to identify and assess key risks in the clinical protocol or set‑up.
* Advise clinical and cross‑functional trial team members on effective mitigation strategies.
* Maintain a consistent quality risk assessment process across the program.
* Provide and lead strategic guidance on quality risk assessments, risk entries, and mitigation strategies.
* Approve Clinical Quality Plans (CQP) risk monitoring information in the quality risk repository to facilitate regular progress reviews.
* Drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews.
* Communicate a strategic framework with business partners and quality management governance to keep them informed on key quality risks and mitigations.
* Facilitate risk updates to R&D Business Partners through regular review cycles via Quality Working Groups and Governance Fora.
* Work with risk owners to develop effective risk mitigation plans at the trial level CQP.
* Highlight new potential systemic risks to RDQ / CRM management.
* Consult, Escalate, and assess compliance issues in consultation with the Head of Clinical Risk Management.
* Develop and enforce consistent interpretation of issues requiring quality investigations.
* Provide guidance for significant quality issues (SQI) per corporate standards and escale SQI to senior R&D management.
* Conduct initial serious breach evaluations of quality issues that may require reporting to Health Authorities.
* Advise on the development and implementation of Corrective and Preventative Action (CAPA) plans and effectiveness checks.
* Lead key inspection processes and inspection tools to maintain ongoing inspection readiness with trial teams.
* Develop inspection narratives, identify and prepare sites for inspection, and coordinate mock inspections with Regulatory Compliance teams.
* Provide front and back room support for Sponsor‑Monitor inspections at J&J sites, including post‑inspection support.
* Provide inspection support per contractual agreements for third‑party inspections (vendors, co‑development partners, and contract research organizations).
* Provide remote support for investigative site inspections, including post‑inspection support.
* Mentor and coach others on inspection support and readiness.
* Provide independent advice on research quality and compliance questions from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts.
* Support and lead the coordination of quality integration of acquired assets or companies, delivering robust documentation within the 90‑day plan.
* Lead general guidance to stakeholders and provide input into Quality Agreements with (Co‑)development partners.
* Facilitate asset divestment requirements and integration as required.
Qualifications
* Minimum of a Bachelor’s degree in a scientific, medical, or related discipline.
* Minimum of 10 years of experience in the healthcare industry (pharmaceutical, contract research organization, or healthcare/hospital system).
* Proven strong GCP Quality and/or clinical trials experience.
* Excellent interpersonal, oral, and written communication skills.
* Flexibility to respond to changing business needs.
* Demonstrated ability to operate in a culturally diverse environment.
* Proficiency in Microsoft Office applications.
* Experience with fundamentals of clinical trial risk management (preferred).
* Experience working according to ICH guidelines (preferred).
* Knowledge of GMP, GLP, and/or Good Pharmacovigilance Practice (preferred).
* Experience with Health Authority inspections (FDA, EMA, and other inspectorates) (preferred).
* Strong project planning and management skills (preferred).
* Experience managing escalations and CAPA support/advisement (preferred).
* Proficiency with data analytics and/or visualization tools (e.g., Tableau, Spotfire) to provide insights for decision‑making (preferred).
* Experience with Data Science and Digital Health, including Real World Evidence or Real World Disease (preferred).
* Proficiency in speaking and writing English.
* Up to 10% travel, primarily domestic with some international travel.
Preferred Skills
* Budget Management
* Clinical Research and Regulations
* Clinical Trials Operations
* Compliance Management
* Compliance Risk
* Continuous Improvement
* Developing Others
* Fact‑Based Decision Making
* Inclusive Leadership
* Leadership
* Operations Management
* Performance Measurement
* Quality Control (QC)
* Quality Management Systems (QMS)
* Quality Standards
* Risk Assessments
* Standard Operating Procedure (SOP)
* Tactical Planning
* Vendor Selection
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