PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide.
PATH’s Essential Medicines and its Center for Vaccine Innovation and Access brings together our expertise across every stage of the long and complex process of drug and vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA’s current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against 15 different diseases. Our focus is on development of vaccines to address the leading diseases that claim children’s lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio, emerging infectious diseases, and meningitis. We Sponsor or partner with Sponsors to conduct vaccine trials worldwide aimed at advancing global public health. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others.
The Trial Master File (TMF) Document Associate will provide primary support to ensure audit readiness of trial master files for clinical trials, reporting into the Trial Master File Manager. The TMF Document Associate will contribute to areas of best practice and process improvement, including staying abreast of Trial Master File Reference Model community updates. The TMF Document Associate will be an integral addition to the advancement of in-house Trial Master File activities and may also participate in management of other, research related quality-related documentation activities.
- Serve as a Veeva eTMF Business Administrator for set up and maintenance of Trial Master Files.
- Provide support in day-to-day maintenance of Sponsor Trial Master Files according to ICH/GCP requirements.
- Generate reports and keep study teams abreast of predefined Trial Master File metrics
- Lead reviews to ensure quality Trial Master File content.
- Maintain issue and action logs, resolve study specific Trial Master File issues.
- Maintain Trial Master File training and access records and ensure ongoing and timely removal of Trial Master File access to external partners.
- Transfer documents from secure locations to Trial Master Files and initiate applicable workflows.
- Track document lifecycles to ensure workflows and approvals meet SOP and Trial Master File Plan specifications.
- Maintain accurate and current Trial Master File content lists and communicate discrepancies to Subject Matter Experts.
- Maintain awareness of study events and ensure content lists are updated accordingly.
- Review Trial Master File content and resolve or communicate issues with metadata, filing locations or improper workflow designation prior to content approval.
- Maintain knowledge of study specific Trial Master File Plans and generate study specific reports on Quality, Completeness and Timeliness to ensure compliance and audit readiness.
- Track audit readiness metrics and implement procedures, as directed, to ensure all study Trial Master Files are maintained in an audit ready state.
- Support requests for document and/or Trial Master File access.
- Support retrieval and storage of Trial Master File records, paper and electronic, from Contract Research Organizations or internal staff.
- Support clinical quality initiatives to maintain Trial Master File Standard Operating Procedures, tools and templates.
- Conduct routine clinical document control activities including routing of documents through workflows, ensure formatting and proper use of templates, provide user level assistance in the document control processes as well as use of the Veeva EDMS system.
- Interface with departments/teams both internally and externally in completing above responsibilities.