Beschreibung

In this leadership role, you will drive the generation of real-world evidence by overseeing complex non-interventional studies while ensuring strict regulatory compliance and high-quality operational execution.

Anforderungen

• •Five years pharmaceutical, CRO, or academic experience
• •Expertise in evidence generation and scientific knowledge
• •Strong project and operational management skills
• •Understanding of drug and device development
• •Cross-functional and multicultural collaboration experience
• •Strong technical and analytical skills
• •Excellent communication and stakeholder management abilities
• •Willingness to travel for study-related meetings

Aufgaben

• •Design and coordinate non-interventional studies
• •Oversee study execution and global regulatory compliance
• •Maintain alignment with GPP, GCP, and ISO standards
• •Complete audit-related corrective and preventive action plans
• •Manage relationships with Affiliates, CROs, and vendors
• •Monitor partner performance and resolve operational issues
• •Lead study teams through coaching and training
• •Drive operational planning and feasibility activities
• •Manage study timelines and supply coordination
• •Track and report on program budgets and metrics
• •Oversee safety reporting and recruitment monitoring
• •Optimize study manuals and operational tools
• •Ensure Trial Master File inspection readiness
• •Manage compliant site close-out and safety reconciliation

Tools & Technologien