Trial Master File Manager

• This position reports to the 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.

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.

• 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.

• 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.

• 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.

Candidate needs to work Onsite (Cambridge, MA) for 2 Days/Month.