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.

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