Manager, Clinical Risk Management

Johnson & Johnson

Manager for Cross Therapeutic Area Clinical Risk Management at Johnson & Johnson. Overseeing trial data integrity and execution of clinical trials with a focus on quality risk management.

Posted 5/14/2026full-timeSpring House • New Jersey, Pennsylvania • 🇺🇸 United StatesSeniorLead💰 $102,000 - $177,100 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformTableau

About the role

Key responsibilities & impact

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.
Executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs).
Ensures compliance with regulatory requirements and internal procedures, and maintains a continued state of inspection readiness.
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.
Communicates and facilitates risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora.
Develops and ensures a consistent interpretation of issues that require quality investigations.
Provides guidance for significant quality issues per corporate standards and escalates significant quality issues to senior R&D management.
Drives ongoing inspection readiness activities with trial teams to develop inspection narratives and coordinates mock inspection in collaboration with Regulatory Compliance teams.

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 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.
Up to 10% travel, primarily domestic with some international travel.

Benefits

Comp & perks

Consolidated retirement plan (pension) and savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year; 48 hours for State of Colorado; 56 hours for State of Washington
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCP Qualityclinical trialsclinical trial risk managementdata analyticsdata visualizationData ScienceDigital HealthReal World EvidenceReal World DiseaseCAPA support

Soft Skills

interpersonal skillsoral communicationwritten communicationflexibilitycultural diversityproject planningproject management