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 conducts vaccine and drug development, including associated technology research and vaccine introduction activities in the following disease areas: malaria, diarrheal diseases and polio, respiratory tract infections and meningitis, HPV and vector-borne viral diseases, as well as in the cross-cutting area of Maternal Immunization.  The EM Clinical Functional Team provides leadership and support to the clinical activities conducted by various programs developing vaccines and drugs for implementation in low-resource settings, including the design of clinical development plans, protocols and related documents, implementation of clinical trials, monitoring and oversight of all trial activities, and support for regulatory submissions leading to local registration and WHO prequalification of new vaccines.

The Trial Master File Manager leads the oversight and management of EM’s in-house Trial Master File (TMF) and oversees internal processes for TMFs outsourced to contractors under the CVIA Clinical Functional Area. This position is responsible for building process, overseeing TMF staff, ensuring TMF audit readiness, and working with subject matter experts to ensure complete and accurate content and efficient management and filing processes.

PRIMARY RESPONSIBILITIES:

+--------------------------------------------------------------------------+ | - Define and manage organization and study level TMF filing procedures | | and ensure efficiency and alignment with functional area and | | institutional requirements. | | - Ongoing development, oversight and maintenance of TMF governance | | documents (e.g, SOPs, TMF Plan template, training materials, | | work instructions). | | - Ensure TMF governance documents and associated resources remain | | current and in compliance with relevant internal SOPs, ICH and GCP | | requirements, evolving business procedures. | | - Develop, review and provide comments on procedures, SOPs or guidance | | documents that impact the TMF. | | - Develop and deliver trainings and refreshers to internal and | | external staff. | | - Routinely assess Veeva eTMF Vault and recommend system changes to | | System Administrator when necessary. | | - Attend Veeva eTMF product release sessions to  determine what | | changes to implement and understand changes that may impact training | | materials and/or procedures. | | - Ensure overall compliance with TMF quality, completeness, and | | timeliness requirements and implement process improvements. | | - Create TMF metrics and routinely inform partners of and Director of | | Clinical Operations of deficiencies | | - Serve as lead contact for audits involving TMFs. | | - Resolve existing TMF records discrepancies through and finalize | | plans to address through point of archival. | | - Oversees work and ensure development of Trial Master File | | Document Associate. | | - Collaborate with unit Directors and applicable functional area Leads | | to address and assess impact of TMF workstream activities. | | - Work with Global Head of Quality or designee to minimize and prevent | | risks associated with Sponsor TMFs. | | - Review partner TMF Plans and ensure alignment with PATH standards | | and ability to maintain TMF audit readiness. | | - Interface with Veeva Managed Services to assess system needs. | | - For TMFs that are outsourced to contractors, creates process and | | leads quality control and archival efforts. | | - Assist with TMF set-up, filing, communications, completeness checks | | and other in-house TMF Document Associate-level duties, when needed, | | depending on TMF Document Associate workload. | | - Lead TMF-specific meetings (including development of agendas, | | minutes, action items, and decisions) and maintain | | study-related documentation. | | - Integrate seamlessly across a cross-functional team in implementing | | TMFs on-time and with high-quality. | | - Demonstrate a sense of urgency in delivering on milestones. | +--------------------------------------------------------------------------+

Required Skills Required Experience

• A minimum of a Bachelor’s of Science in a scientific/medical/pharmaceutical discipline.
• A minimum 5 years direct experience working in clinical TMFs and 3 years TMF management experience.
• Veeva eTMF Business Administrator experience required.
• Demonstrated experience developing procedures and implementing processes that improve quality.
• Extensive knowledge of ICH-GCP guidelines and FDA regulations.
• Familiarity with EMA GCP and MHRA TMF guidance. 
• Subject Matter Expert level knowledge TMF Reference Model (RM) and Sponsor TMFs 
• Familiarity with TMF RM working group initiatives.
• Demonstrated ability to identify and resolve issues.
• Attention to detail and accuracy.
• Experience with clinical trials in international settings.
• Working knowledge of clinical trials of all phases. 
• Effective timeline management.
• Ability to analyze information, review reports and prioritize actions.
• Ability to work well in a team environment, both as a leader and a contributor.
• Open, engaging, collaborative, and transparent work style.
• Global perspective and mindset; ability to work effectively with colleagues from other cultures.
• Strong verbal and written communication skills.

Must have legal authorization to work in the United States.

PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, gender identity or orientation, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

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