Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team located at an office in Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; and Basel, Switzerland.
The Manager, Cross TA Clinical Risk Management, works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well‑being, or rights. Throughout the duration of the trial/program, this Manager executes data‑driven, risk‑based trial oversight activities to deliver quality in the execution of clinical trials and programs, comply with regulatory requirements and internal procedures, and maintain a continued state of inspection readiness.
Key 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.
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 the 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).
Highlights 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 coordinate mock inspections 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.
Qualifications
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 are 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 GMP, GLP, and/or GPvP is preferred.
Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
Strong Project Planning/Management skills are preferred.
Experience in managing escalations and CAPA support/advisement is preferred.
Experience with data analytics and/or data visualization tools (e.g., 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
In addition to base pay, we offer an annual bonus with set target (% of pay) depending on pay grade / location, vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees – and in some locations eligible dependents – can participate in several insurance plans.
This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers.
#J-18808-Ljbffr