Global Clinical Risk Manager - Cross-TA

Johnson & Johnson Innovation; Allschwil; Vor Ort; CHF 130.000 - 180.000; Vollzeit

Zusammenfassung

Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team in Basel, Switzerland. The role coordinates the identification, assessment, and mitigation of quality risks that could affect trial data integrity, patient safety, well-being, or rights, and ensures ongoing trial/program oversight.

The job requires leading risk reviews, maintaining quality plans, driving CAPA plans, and supporting inspections across multiple

Qualifikationen

• Bachelor’s degree in a scientific, medical, or related discipline.
• Minimum 8 years in healthcare, pharma, CRO or hospital systems.
• Proven strong GCP quality and/or clinical trials experience.
• Excellent interpersonal, oral and written communication skills.
• Proficiency with data analytics tools is preferred.
• Proficiency in English required.

Aufgaben

• Actively participates in study activities, identifying key risks and advising on mitigations.
• Leads regular risk reviews with Risk Owners to evaluate mitigations and new risks.
• Maintains Clinical Quality Plans in quality repository for reviews and risk data.
• Drives quality risk monitoring reviews and coaches others in risk reviews.
• Communicates risk updates to RDQ and trial teams for governance forums.
• Supports CAPA development and effectiveness checks with RDQ partners.
• Supports inspection readiness activities and site preparation for inspections.
• Provides independent guidance on regulatory questions to ensure compliance.

Kenntnisse

GCP quality

Clinical trials

Interpersonal skills

Written communication

Cross-functional

Flexibility

English proficiency

Data analytics

Microsoft Office

Ausbildung

Bachelor’s degree (scientific, medical, or related discipline)

Tools

Tableau

Spotfire

Jobbeschreibung

Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team in Basel, Switzerland. The role coordinates the identification, assessment, and mitigation of quality risks that could affect trial data integrity, patient safety, well-being, or rights, and ensures ongoing trial/program oversight.

The job requires leading risk reviews, maintaining quality plans, driving CAPA plans, and supporting inspections across multiple