TMF Officer

TMF Officer – Drugs for Neglected Diseases initiative (DNDi) Join to apply for the TMF Officer role at Drugs for Neglected Diseases initiative (DNDi) . The Research and Development Department includes three clusters of disease expert teams: NTD Mycetoma and Leishmaniasis; NTD Chagas, Filarial, and HAT; and Viral Diseases. These teams drive therapeutic innovation from the lab bench to the patient bedside, advancing DNDi’s portfolio of treatment candidates from the outset (with the design of target product profiles) to the end point (enabling patients’ access to new treatments). DNDi established its Latin American office in Rio de Janeiro in 2004. Since then, DNDi Latin America has made extensive contributions to advancing R&D and access partnerships across the region’s diverse health ecosystems. Its work spanning neglected diseases such as Chagas disease, leishmaniasis, hepatitis C, and dengue plays a central role in delivering DNDi’s global strategy. The office also leads advocacy efforts and drives capacity‑building initiatives through multi‑country clinical research and drug discovery platforms. The Trial Master File Management Officer is responsible for compiling, maintaining and archiving all TMF‑related documents to prepare submissions to any international authorities for one or more drug registrations, and to comply with DNDi’s SOPs and GCP requirements for filing and archiving of clinical trials. The incumbent will plan and coordinate the overall management of the Trial Master Files and associated processes following GCP and ICH, including system and tool development, business process documentation, and ensuring inspection readiness for the TMF across all Disease Programme/Cluster. Responsibilities Manage document control processes and systems for GCP activities in compliance with internal procedures and policies and ensure compliance with ICH/GCP and relevant international and local legislation and regulations. Assess suitability of documentation for filing (accuracy, completeness, and legibility). Ensure high‑quality Trial Master File set‑up and management (on‑boarding of study contributors, completion of the Trial Master File management plan, study‑specific preparation of documents in the system, periodic reviews, etc.). Serve as a Trial Master File contact for documentation with the project team and cross‑functional departments. Follow up on open record‑management queries and ensure their full resolution. Assist in periodic Trial Master File audits. Plan and perform internal periodic quality check activities of the Trial Master File, provide findings to the clinical team and provide support to ensure compliance meets internal and external quality standards. Support clinical teams during regulatory inspections for record organization and retrieval. Continuously monitor, identify and report quality problems and record‑management work practices, recommend resolutions, and initiate actions required to resolve quality and efficiency problems. Additional / Specific / Projects Responsibilities Support the creation and/or update of applicable SOPs, Guidance Documents, templates etc., as applicable. Continuously oversee and identify rooms for improvement for document management processes, particularly in archiving management, and support implementation activities as applicable. Report to the Senior Clinical Project Manager. Work with all teams and units in all departments. Coordinate with external contacts under supervision and support information exchange. Hold at least a first university degree (Bachelor level) in a relevant field if required by the function. Have at least 3 years of experience or equivalent internship/training in the area. Proven ability to work effectively in a team environment and matrix structure. Experience working in the public and private sector is highly desirable. Critical Skills And Attributes Emerging technical skills in a defined field. Ability to support standard and routine activities independently. Willingness to learn and apply feedback to evolve into higher‑level specialist roles. Ability to use initiative, prioritize, multi‑task, and work well under pressure to meet deadlines. Clear and systematic thinking that demonstrates good judgment and problem‑solving competencies. Ability to work effectively as part of a multicultural team. Well‑organized and structured. Good analytical skills. Provide specialist services to operational line or project team. Ability to solve non‑routine problems on a case‑by‑case/project basis. Has certain autonomy for taking actions and decisions. R&D Technical Skills Good knowledge of regulatory (GCP, GLP and GMP) particularly in TMF management. Strong technical writing skills (procedures, protocols and reports). Fluency in English. Proficiency in local languages desirable. Excellent knowledge of Microsoft Suite. Good knowledge of Veeva (eTMF maintenance, improvement, review release, set‑up, etc.). DNDi is committed to building a diverse, equitable and truly inclusive organisation. Our success and global reach are dependent upon our ability to encourage diversity and draw on the skills, understanding and experience of all our people. We particularly welcome applications from those who are under‑represented in DNDi and across the sector, especially women, and including, but not limited to, Black and minority ethnic candidates, and those with other protected characteristics. Senior​ity Level Mid‑Senior level Employment Type Full‑time Job Function Other Industries Research Services #J-18808-Ljbffr