Join a dynamic team as a Trial Master File Associate, managing TMF content for study life cycles in a hybrid working setting. Ensure compliance and organization in TMFs while interacting with cross-functional teams. This full-time TMF Associate role focuses on managing content from study setup to archiving.
You'll work closely with study teams during audits, maintain an organized electronic file repository, and promote company practices. This position requires collaboration within a cross-functional team dynamic. Key Responsibilities:
- Serve as primary TMF contact for studies
- Ensure TMF is inspection-ready throughout the lifecycle
- Develop study-specific TMF management documents
- Maintain quality control schedules for TMF completeness
- Provide training to internal and external stakeholders Requirements:
- College diploma/degree and 1-3 years of experience
- Understanding of TMF organization and regulations
- Strong time management and problem-solving skills
- Proven Microsoft Office proficiency
- Ability to apply ALCOA principles effectively Elevate your career in TMF operations with a focus on quality and compliance.