Associate Director Trial Master File(m/w/x)

In this role, you will oversee TMF compliance and quality across clinical trials, ensuring readiness for inspections and effective documentation practices. You will collaborate with various teams, manage vendor relationships, and drive continuous improvement in TMF operations.

Anforderungen

• •University degree or comparable professional education in medicine, life sciences, paramedical sciences, information management, or business administration
• •More than 8 years of relevant experience in a regulated clinical development environment
• •Minimum of 8 years in the pharmaceutical industry or clinical development roles
• •At least 5 years of TMF-focused responsibilities
• •Broad experience across TMF lifecycle management
• •Proven ability to lead TMF initiatives across cross-functional, global teams
• •Demonstrated leadership in preparing for and participating in TMF audits and inspections
• •Experience working with and overseeing TMF vendors and CROs
• •Expert-level knowledge of TMF management frameworks
• •Proven ability to serve as a Subject Matter Expert in TMF systems
• •Experience with TMF governance, metrics, inspection readiness, and continuous process improvement
• •Demonstrated ability to develop and maintain TMF-related SOPs and training programs
• •Strong analytical and decision-making skills
• •Excellent written and verbal communication skills
• •High level of accountability and attention to detail
• •Proficiency in Microsoft Office and other clinical systems