Manager, Clinical Risk Management

Johnson & Johnson

. Coordinate the identification, assessment, and mitigation of quality risks affecting trial data integrity, patient safety, well-being, or rights .

Posted 10/2/2026full-timeUnited StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality risk management and clinical trial oversight, with a strong focus on Good Clinical Practice (GCP) and compliance with regulatory standards. Proficient in data analytics and effective communication within cross-functional teams to ensure trial integrity and patient safety.

Highest-signal resume keywords

GCP Quality ExperienceClinical Trial Risk ManagementData Analytics ProficiencyHealth Authority Inspection ExperienceProject Planning/Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial OversightRisk AssessmentQuality Risk MonitoringCorrective and Preventative Action PlansData InterpretationQuality InvestigationsInspection ReadinessProtocol Risk AssessmentQuality Plan MaintenanceData Visualization

Soft Skills

Interpersonal CommunicationCollaborationFlexibilityCultural AwarenessWritten Communication

Tools & Technologies

Microsoft Office ApplicationsTableauSpotfire

Industry Keywords

Pharmaceutical IndustryContract Research OrganizationGood Manufacturing PracticeGood Laboratory PracticeGood Pharmacovigilance PracticeICH GuidelinesReal World EvidenceReal World Disease

Tech Stack

Tools & technologies

Google Cloud PlatformTableau

About the role

Key responsibilities & impact

Coordinate the identification, assessment, and mitigation of quality risks affecting trial data integrity, patient safety, well-being, or rights
Execute data-driven, risk-based trial oversight activities throughout the trial/program
Participate in study activities, identify and assess protocol/setup risks, and advise clinical team members on mitigation strategies
Review risk areas with Risk Owners and evaluate risk mitigation and reduction progress
Maintain Clinical Quality Plans in the quality repository
Drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews
Communicate risk updates through Quality Working Groups and Governance Fora
Highlight potential systemic risks to RDQ CRM management
Develop consistent interpretations of issues requiring quality investigations
Provide guidance on significant quality issues and escalate them to senior R&D management
Advise on Corrective and Preventative Action Plans and Effectiveness Checks
Drive inspection readiness activities, including inspection narratives, site preparation, key document availability, and mock inspections
Support Investigator, Sponsor-Monitor, and third-party inspections, including post-inspection activities
Provide advice on research quality and compliance questions in collaboration with Quality Professionals and Subject Matter Experts

Requirements

What you’ll need

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
Requires proficiency in speaking and writing English
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

Benefits

Comp & perks

Inclusive work environment
Disability accommodation support during the interview process
Up to 10% travel, primarily domestic with some international travel