Manager, Clinical Risk Management

Johnson & Johnson seeks a Manager of Clinical Risk Management in Allschwil to oversee trial quality, regulatory compliance, and risk mitigation strategies within the R&D Quality CRM team.

This position sits within the R&D Quality CRM team and partners with trial and program groups to coordinate the identification, assessment, and mitigation of risks. The role executes risk-based oversight to guarantee quality standards, regulatory compliance, and readiness for inspections.

Responsibilities

• Engages in study activities to pinpoint and evaluate key risks within clinical protocols, offering advice on mitigation strategies.
• Conducts regular reviews with Risk Owners to assess the progress of mitigation efforts and detect emerging risks.
• Updates Clinical Quality Plans in the quality repository to support progress tracking and reviews.
• Leads quality risk monitoring reviews and mentors colleagues on risk monitoring and mitigation techniques.
• Shares risk updates with R&D colleagues via Quality Working Groups and Governance Fora.
• Alerts RDQ CRM management to potential systemic risks.
• Ensures consistent interpretation of issues that require quality investigations.
• Guides the handling of Significant Quality Issues according to corporate standards and escalates matters to senior leadership when necessary.
• Advises on the creation and implementation of Corrective and Preventative Action plans and their effectiveness checks.
• Manages ongoing inspection readiness activities, such as developing narratives, preparing sites, and coordinating mock inspections.
• Supports Investigator, Sponsor-Monitor, and third-party inspections, including post-inspection follow-up.
• Provides independent advice on research quality and compliance questions to clinical teams.

Requirements

• Bachelor’s degree in a scientific, medical, or related field.
• At least 8 years of experience in the healthcare industry, including pharmaceuticals, CROs, or hospital systems.
• Strong background in GCP Quality and/or clinical trials.
• Excellent interpersonal, oral, and written communication skills for cross-functional collaboration.
• Flexibility to adapt to changing business needs.
• Ability to work in culturally diverse environments and understand regional/global business structures.
• Proficiency in Microsoft Office Applications.
• Proficiency in speaking and writing English.

Nice to have

• Experience with fundamentals of clinical trial risk management.
• Experience working to ICH guidelines.
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP).
• Health Authority Inspection experience (FDA, EMA, and other inspectorates).
• Strong Project Planning/Management skills.
• Experience in managing escalations and CAPA support/advisement.
• Proficiency with data analytics and/or data visualization tools (e.g., Tableau, Spotfire) to analyze data and drive decision-making.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease).

What the company offers

• Inclusive work environment where each person is considered as an individual.
• Commitment to respecting the diversity and dignity of employees and recognizing their merit.
• Opportunity to work on teams that save lives by developing medicines of tomorrow.
• Commitment to providing an inclusive interview process and accommodations for individuals with disabilities.

About the company

Johnson & Johnson operates with the belief that health is everything, aiming to build a world where complex diseases are prevented, treated, and cured. Guided by its Credo, the company is responsible to its employees worldwide and champions patients every step of the way from lab to life.

• The company believes health is everything and aims to build a world where complex diseases are prevented, treated, and cured.
• The company is guided by its Credo and is responsible to its employees worldwide.
• The company champions patients every step of the way from lab to life.