TMF Manager- Clinical Operations

About This Role

This role manages and maintains the company's Trial Master Files (TMFs), ensuring they are current and inspection-ready for internal and external entities. The position involves performing setup activities, overseeing e/TMF applications, and supporting Clinical Operations Study Leaders.

Responsibilities

• Manage clinical document quality, control, and review, and the Trial Master Files (TMFs)
• Perform set up activities and oversight of internal e/TMF applications
• Support Clinical Operations Study Leaders in the QC and oversight of CROs’ e/TMF applications
• Function as lead for specified e/TMF platform with vendor(s)
• Provide support and guidance to CROs and support staff for accurate and timely eTMF filing and maintenance according to ICH GCP guidelines
• Provide training to eTMF users and external parties (CROs)
• Partner with management to support functional and organizational initiatives, drive new procedures and ideas, and advocate for processes and decisions
• Support the development and review of standard operating procedures and work instructions related to clinical document management
• Contribute to maintenance of written instructions, SOPs, guidelines, and plans related to e/TMFs and document control
• Update and maintain Naming and Filing Guide(s) for relevant e/TMF systems

Requirements

• 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 including development of SOPs, user training manual, performing UATs and validations
• 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

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

Nice to Have

• Motivated self-starter 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 with a high degree of attention to detail

Skills

* Required skills