Specialist Clinical Risk Management Oncology

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

4d•$79,000 - $127,650•Hybrid

About The Position

Johnson & Johnson is currently seeking a Specialist, Clinical Risk Management Oncology to join our R&D Quality CRM team. This role focuses on coordinating the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well-being, or rights. The Specialist will execute data-driven, risk-based trial oversight activities to ensure quality in trial execution, compliance with regulatory requirements and internal procedures, and maintain inspection readiness. This role is available across multiple countries including the United States, Belgium, and the United Kingdom.

Requirements

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.
Requires proficiency in speaking and writing English.

Nice To Haves

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).

Responsibilities

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.
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.
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.
Provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks.
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, ensures availability of key documents/records and coordinates mock inspection.
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.

Benefits

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
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program