What will you do?
This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above).
This role maintains the company's 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.
- What will be your 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
- What qualifications do we require? 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
- 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
- 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 n