Assoc Director, Clinical Risk Management in Basel

Overview

In this role you will lead cross-therapy risk management for clinical trials, driving data‑driven risk oversight to safeguard data integrity and patient safety. You will collaborate with trial teams across regions to ensure regulatory compliance and inspection readiness, shaping quality strategies and CAPA plans. This is a strategic, hands‑on position that influences how trials and programs mitigate risks and deliver high‑quality results. You will work with diverse, cross‑functional teams and contribute to continuous improvement in clinical risk management.

Verantwortungsbereiche

• Identify and assess key risks in clinical protocols and setups and advise on mitigation strategies
• Lead regular reviews of risk areas with Risk Owners to track progress and identify new risks
• Maintain Clinical Quality Plans (CQP) in a quality repository for ongoing reviews of quality support and risk mitigations
• Drive quality risk monitoring reviews and coach others on risk monitoring and mitigation
• Communicate risk updates to R&D colleagues through Quality Working Groups and Governance Fora
• Provide guidance on quality investigations and escalation of Significant Quality Issues (SQI) to senior management
• Collaborate with RDQ on CAPA development and effectiveness checks
• Support inspection readiness activities, including mock inspections and site preparation
• Provide expert advice on research quality and regulatory interpretation with cross‑functional stakeholders
• Participate in cross‑R&D and cross‑functional groups to refine processes, tools, and systems
• Provide training and coaching to peers and new employees

Zentrale Anforderungen

• Bachelor’s degree in scientific, medical, or related discipline
• 8+ years in healthcare/pharma/CRO/healthcare system with GCP quality or clinical trials experience
• Strong interpersonal, oral, and written communication skills for cross‑functional collaboration
• Flexibility to adapt to changing business needs and diverse regional contexts
• Proficiency in Microsoft Office
• Experience with clinical trial risk management and ICH guidelines
• Knowledge of GMP/GLP/GPvP preferred
• Health Authority inspection experience (FDA/EMA) required
• Project planning/management skills (preferred)
• Experience with data analytics and data visualization tools (Tableau, Spotfire) and/or Data Science/Digital Health (preferred)
• English language proficiency
• Up to 10% travel (domestic and some international)

• cross-functional collaboration
• effective communication
• adaptability
• GCP quality
• CAPA and SQI management
• risk assessment and mitigation