Senior Associate I, Tmf Operations
Current– ensure a complete, accurate, and high quality Trial Master File (TMF) throughout trial using knowledge of ICH-GCP standards & relationships with Project Team– perform periodic TMF Quality Control checks to ensure adherence to regulatory, Sponsor, and industry-best practices– report & maintain TMF metrics for assigned studies to Project Managers and Sponsors on a monthly basis– work with variety of Electronic Document Management and electronic TMF Systems– escalate Project Team members to resolve emergency TMF quality issues in timely manner– prepare and transmit TMF and other critical documents to Sponsor in accordance with relevant instructions– support, comply, and heed Regulatory and Sponsor auditsAdditional RoleRMC Mentor: invest weekly in development of Junior Associate & Senior Associate Mentee through relationship building & knowledge sharing