Risk Management Specialist – Oncology

Johnson & Johnson

Specialist in Clinical Risk Management overseeing trial data integrity and patient safety at Johnson & Johnson. Collaborating with cross-functional teams on quality risk mitigation and regulatory compliance.

Posted 5/26/2026full-timeTitusville • New Jersey, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $79,000 - $127,650 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
Participates in 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
Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations
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 R&D management.
Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities
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)
Supports proactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensures 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 advice on questions related to research quality and compliance from Business Partners 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 4 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required.
Excellent interpersonal, oral, and written communication skills
GCP quality and/or clinical trials experience
Experience collaborating in a cross-functional team environment
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, preferably in a global setting
Experience working to ICH guidelines
Health Authority Inspection experience (FDA, EMA and other inspectorates)
Strong Project Planning/Management skills
Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)
Proven ability to analyze & interpret collective data to provide insights to drive decision-making
Experience in managing escalations and CAPA support/advisement
Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)
Requires proficiency in speaking and writing English.

Benefits

Comp & perks

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
10 days 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 trials experienceclinical trial risk managementdata analyticsdata visualizationCAPA supportdata sciencedigital healthreal world evidencereal world disease

Soft Skills

interpersonal skillsoral communicationwritten communicationflexibilitycross-functional collaborationcultural awarenessproject planningproject managementanalytical skillsdecision-making