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 compliance within clinical trials, ensuring data integrity and patient safety. Proficient in developing and executing risk mitigation strategies while effectively communicating with cross-functional teams.

Highest-signal resume keywords

GCP Quality ExperienceClinical Trials ExperienceRisk Management FundamentalsHealth Authority Inspection ExperienceProject Planning/Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Risk ManagementData AnalyticsData VisualizationClinical Quality PlansCorrective and Preventive Action PlansInspection-Readiness ActivitiesSignificant Quality Issues GuidanceInternational Regulations InterpretationClinical Trial OversightRisk Monitoring

Soft Skills

Interpersonal SkillsCommunication SkillsFlexibilityCultural AwarenessCollaboration

Tools & Technologies

Microsoft Office ApplicationsTableauSpotfire

Industry Keywords

Healthcare IndustryPharmaceutical IndustryContract Research OrganizationGood Manufacturing PracticeGood Laboratory PracticeGood Pharmacovigilance PracticeICH GuidelinesReal World EvidenceReal World DiseaseFDA Inspection

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 clinical trials and/or programs.
Participate in study activities and advise clinical team members on effective risk mitigation strategies.
Review risk areas with Risk Owners and identify new risks or additional mitigation needs.
Maintain Clinical Quality Plans in the quality repository.
Drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews.
Communicate and facilitate risk updates through Quality Working Groups and Governance Fora.
Highlight potential systemic risks to RDQ CRM management.
Develop and ensure consistent interpretation of issues requiring quality investigations.
Provide guidance on Significant Quality Issues and escalate them to senior R&D management.
Advise on Corrective and Preventive 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 independent advice on research quality and compliance and ensure consistent interpretation of international regulations and policy.

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.
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) 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.

Benefits

Comp & perks

Inclusive work environment
Equal employment opportunity
Interview process accommodations for applicants with disabilities
Up to 10% travel, primarily domestic with some international travel