Manager, Clinical Risk Management

Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team. 

As a Manager, Clinical Risk Management you will:

The 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 on 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/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

The responsibilities and the impact YOU will have:

• Actively 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.
• Leads 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).
• Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations
• Independently drives quality risk monitoring reviews and coach’s others on risk monitoring and mitigation reviews
• Communicates and facilitates 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 risks to RDQ CRM management.
• Develops and ensures a consistent interpretation of issues that require quality investigations
• Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.
• In 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)
• Drives 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.
• Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support
• Provides 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.

We would love to hear from YOU, if you have the following essential 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.
• Proven strong GCP Quality and/or clinical trials experience is required.
• Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
• Flexibility to respond to changing business needs is required.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
• Proficiency in Microsoft Office Applications is required.
• Experience with fundamentals of clinical trial risk management is preferred.
• Experience working to ICH guidelines is preferred.
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
• Strong Project Planning/Management skills is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.
• Experience 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.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
• Requires proficiency in speaking and writing English.
• Up to 10% of 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, Team Management, Vendor Selection

Hybrid Work