Manager, Clinical Risk Management

Johnson & Johnson

Manage Clinical Risk in innovative medicine at Johnson & Johnson. Oversee risk identification, assessment, and mitigation for clinical trials.

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

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 coaches 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 risk 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.

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) 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% travel, primarily domestic with some international travel.

Benefits

Comp & perks

Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
Participate in the Company’s long-term incentive program
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
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 trialsrisk managementCAPA Plansinspection readinessdata analyticsdata visualizationData ScienceDigital HealthReal World Evidence

Soft Skills

interpersonal skillsoral communicationwritten communicationflexibilitycultural awarenesscollaborationproject planningmanagement skills