TMF Manager - Contractor - The Steely Group

This position reports to a Sr. Manager or Associate Director of Clinical Operations. 

This role maintains TMFs ensuring they are current and inspection-ready for internal and external entities. The right candidate will possess an understanding of clinical trial conduct, TMF structure (DIA Reference Model), eTMF systems, and best documentation practices.   

Responsibilities:

• Responsible for managing clinical document quality/control/filing, and the Trial Master Files (TMFs). 
• Performs set up activities, document filing and oversight of internal e/TMF applications 
• Supports Clinical Operations Study Leaders in the QC and oversight of CROs’ e/TMF applications 
• Functional lead for specified e/TMF platform with vendor(s) 
• Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines 
• Provide training to eTMF users and external parties (CROs) 
• Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisions 
• Supports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate 
• Creates and maintains written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document control 
• Updates and maintains Naming and Filing Guide(s) for relevant e/TMF systems 
• Work in collaboration with all applicable functional areas 
• Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate 

Requirements / Qualifications: 

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field 
• Minimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization 
• Thorough knowledge of all sections of the DIA Reference Model (current version) 
• Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements 
• Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles 
• Experience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc. 
• Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals 
• Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• Creative problem solver with excellent communication and public speaking skills.
• Proficiency in developing and delivering educational materials, both written and oral 
• Ability to engage in cross-functional interactions with internal and external staff 
• Global trial experience 
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.