Clinical Document Management Specialist
3 days ago
We are seeking a highly motivated Clinical Document Management Specialist to join our team at Beacon Hill Life Sciences in Boston. As a key member of our clinical operations team, you will play a critical role in maintaining client's Trial Master Files (TMFs), ensuring they are current and inspection-ready for internal and external entities.
About the RoleThe successful candidate will possess an understanding of clinical trial conduct, TMF structure (DIA Reference Model), eTMF systems, and best documentation practices. Key responsibilities will include managing clinical document quality/control/filing, and the TMFs, as well as performing set up activities, document filing and oversight of internal e/TMF applications.
Key Responsibilities- Manage Clinical Documents: Responsible for managing clinical document quality/control/filing, and the Trial Master Files (TMFs).
- eTMF Applications: Perform set up activities, document filing and oversight of internal e/TMF applications.
- Clinical Operations Support: Support Clinical Operations Study Leaders in the QC and oversight of CROs' e/TMF applications.
- eTMF Platform Lead: Functional lead for specified e/TMF platform with vendor(s).
- User Support: Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines.
- Training and Development: Provide training to eTMF users and external parties (CROs).
- Process Improvement: 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.
- SOP Development: Supports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate.
- Guidelines and Plans: Creates and maintains written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document control.
- Naming and Filing Guide: Updates and maintains Naming and Filing Guide(s) for relevant e/TMF systems.
- Education: Bachelor's degree or equivalent combination of education/experience in science or health-related field.
- eTMF Experience: Minimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization.
- TMF Knowledge: Thorough knowledge of all sections of the DIA Reference Model (current version).
- Document Knowledge: Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements.
- ICH GCP Knowledge: Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles.
- eTMF System Experience: Experience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc.
- Electronic TMF Application: Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals.
Beacon Hill Life Sciences is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
Average Salary: $85,000 - $110,000 per year
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