Senior Specialist, Clinical Risk Management

Job Overview

Senior Specialist, Clinical Risk Management – Quality CRM team at Johnson & Johnson.

• Horsham, Pennsylvania, United States of America
• Spring House, Pennsylvania, United States of America
• Titusville, New Jersey, United States of America
• Raritan, New Jersey, United States of America

• Actively participate in all study activities, contributing to identification and assessment of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.
• Participate in regular review of risk areas with Risk Owners to evaluate progress of risk mitigations, identify new risks, and determine additional mitigation needs (trial and/or compound).
• Maintain Clinical Quality Plans (CQP) in the quality repository to facilitate progress reviews of quality support services, risks, and mitigations.
• Collaborate closely with risk owners to evaluate mitigation actions and effectiveness checks.
• Communicate and facilitate risk updates to R&D colleagues through Quality Working Groups and Governance Fora.
• Highlight new potential systemic risk to RDQ CRM management.
• Develop and ensure consistent interpretation of issues requiring quality investigations.
• Provide guidance for Significant Quality Issues (SQI) in line with corporate standards and expand SQI to senior R&D management.
• Provide initial serious breach evaluation of quality issues that may require reporting to Health Authorities.
• Collaborate with RDQ partners to advise on development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks.
• Support proactive inspection readiness activities throughout the study, including mock inspection support.
• Provide support for Investigator, Sponsor‑Monitor and third‑party inspections, including post‑inspection support.
• Provide advice on research quality and compliance questions to Business Partners and other Quality professionals to ensure consistent interpretation of international regulations.

• Minimum Bachelor’s degree in a scientific, medical, or related discipline.
• Minimum 6 years of experience in pharmaceutical industry, contract research organization, or healthcare/hospital system.
• 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.
• Demonstrated ability to operate in a culturally diverse environment with understanding of regional and global business structures.
• Proficiency in Microsoft Office applications.
• 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 or data visualization tools (Tableau, Spotfire, or related).
• Proven ability to analyze and interpret collective data to provide insights for decision‑making.
• Experience managing escalations and CAPA support/advisement.
• Experience with Data Science and Digital Health (including Real‑World Evidence/Real‑World Disease).
• Proficiency in speaking and writing English.
• Up to 10% travel, primarily domestic with some international travel.

• Audit Management
• Business Alignment
• Business Savvy
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching
• Collaborating
• Communication
• Compliance Management
• Data Analysis
• Escalation Management
• Fact‑Based Decision Making
• Problem Solving
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Tactical Thinking
• Vendor Selection

• Base pay range: $94,000.00 – $
• Additional Description for Pay Transparency:
  Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Benefits include Vacation, Sick Time, Holiday Pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, and Military Spouse Time‑Off. (Refer to company benefits page for complete details.)

• Vacation – 120 hours per calendar year
• Sick…