Associate Director, TMF Process, Systems and Training

Premier Research is seeking an Associate Director, TMF Process, Systems, and Training to join the Pharmacovigilance and Records Management team. In this role, you will play a pivotal part in assisting biotech, medtech, and specialty pharma companies in translating groundbreaking ideas and scientific advancements into new treatments. Your work will directly impact saving and enhancing lives, highlighting the invaluable contribution of our team members towards achieving success. As an essential member of our team, you will be instrumental in driving the improvement of TMF processes, systems, and training within Global Records Management (GRM). Collaborating with Departmental Leadership, you will oversee the management of GRM staff and take charge of TMF processes and systems utilized in the management of Trial Master Files (TMFs) on a global scale. Your strategic leadership will be crucial in addressing complex issues, optimizing TMF management services, and ensuring compliance with regulations and guidelines. Additionally, you will be responsible for cultivating a high-performing team, overseeing training activities, and leading efforts to address TMF-related issues. To excel in this role, you should possess a minimum of an undergraduate degree in records and information management, clinical, science, or a related field. You must have extensive experience in TMF management processes, systems, and training within the CRO, pharmaceutical, or medical device industry. Proficiency in systems training with platforms like Trial Interactive, Veeva Vault, and/or Wingspan is essential. Strong knowledge of ICH-GCP guidelines and global regulations related to TMF management is required. Excellent interpersonal and communication skills are vital, along with the ability to adapt to changing requirements in a fast-paced environment. You should also demonstrate leadership skills, organizational capabilities, and a customer-centric approach in your work. In summary, as the Associate Director, TMF Process, Systems, and Training at Premier Research, you will play a pivotal role in ensuring the efficient and compliant management of TMFs, contributing to the delivery of high-quality medical innovations. If you are seeking a challenging yet rewarding opportunity to make a meaningful impact in the field of biotech, we invite you to join us and build your future at Premier Research.,