TMF Manager

Job Title: TMF Manager- Clinical Operations Location: Cambridge, MA (Remote) Duration: 12 months Pay rate: $90/hr. This person must be available to work onsite 1-2 times per month and may be short notice. What will you do: • This position reports into Associate Director of TMF Operations (or above). • This role maintains Company Medicines 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 (TMF Reference Model), eTMF systems, and best documentation practices. What will be your responsibilities: • We have a dedicated TMF Operations Team that supports the study team in managing TMF Activities. • Responsible for managing clinical document quality/control/review, and the Trial Master Files (TMFs). • Performs set up activities, 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 • Contributes to maintenance of 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 Education: • 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 TMF Reference Model (current & previous versions) • 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 What qualifications do we prefer: • 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 • Experience working with multiple eTMF vendors and CRO partners. What capabilities do you bring: • 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. Apply tot his job Apply To this Job