Beschreibung

In this role, you will lead a team focused on enhancing clinical operations across Europe, ensuring compliance and efficiency while driving innovative strategies. Your day-to-day responsibilities will involve overseeing trial management, coordinating training, and collaborating with various stakeholders to improve processes.

Anforderungen

• •University degree in Life Sciences, Natural Sciences, or related healthcare field
• •Strong track record in sponsor oversight for Phase II/III trials
• •In-depth knowledge of ICH E6(R2/R3), EU CTR, EMA/FDA inspection behaviors
• •Strong leadership and functional management skills
• •Effective communication in English; German is a plus
• •Motivation and openness to teamwork

Aufgaben

• •Lead clinical operational excellence initiatives
• •Ensure compliance with GCP, SOPs, and regulatory requirements
• •Oversee TMF services and trial oversight for clinical studies
• •Manage Key Performance Indicators and TMF vendor oversight
• •Implement proactive risk mitigation strategies
• •Drive innovative approaches for clinical trial oversight and training
• •Identify and implement process improvements
• •Lead cross-functional initiatives to standardize clinical operations
• •Coordinate training and maintain accurate training records
• •Prepare documentation for audits and regulatory inspections
• •Track CAPAs and review trial-related manuals and plans
• •Collaborate with Clinical Trial Management, Data Management, and QA
• •Provide structured leadership through goal setting and coaching
• •Develop relationships with internal and external stakeholders
• •Continuously improve operational processes and compliance standards

Benefits