Manager, Clinical Risk Management

About This Role

This role is for a Manager of Cross Therapeutic Area Clinical Risk Management, joining the R&D Quality CRM team. The manager coordinates the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well-being, or rights, working with trial and program teams. This involves executing data-driven, risk-based trial oversight activities to ensure quality in clinical trial execution, compliance with regulatory requirements, and continuous inspection readiness.

Responsibilities

• Actively participate 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
• Lead 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)
• Maintain CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations
• Independently drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews
• Communicate and facilitate 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
• Develop and ensure a consistent interpretation of issues that require quality investigations
• Provide guidance for significant quality issues (SQI) per corporate standards and escalate SQI to senior R&D management
• In collaboration with partners in RDQ, provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self-Identified, Inspection, Audit)
• Drive 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 inspection in collaboration with Regulatory Compliance teams
• Provide support for Investigator, Sponsor-Monitor and third-party inspections including post-inspection support
• Provide 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

Requirements

• 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