Sobre

• About the Department
• 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 patientbedside, advancing DNDi’s portfolio of treatment candidates from the outset (with the design of target product profiles) to theend point (enabling patients’ access to new treatments).
• About the Office
• 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.
• Overview
• The Trial Master File Management Officer is responsible to compile, maintain and archive all TMF related documents in order to prepare the submissions to any international authorities for one or several different drug registrations and to comply with DNDi’s SOPs and GCP requirements for filing and archiving of clinical trials. The incumbent will plan and coordinates the overall management of the Trial Master Files and associated processes following GCP and ICH, including system and tool development, business process documentation and is ultimately responsible to ensure 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 to 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 the team to ensure compliance is maintained to meet internal and external quality standards.• Provide support to clinical teams during regulatory inspections for record organization and retrieval.
• • Continuously monitor, identify and report quality problems and record management work practices, make recommendations for 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, in particular in the areas of archiving management. Support implementation activities as applicable.
• Reporting line & Interactions
• TMF Officer reports to Senior Clinical Project Manager.
• Works with all teams, and all units in the all departments.
• Coordinate with external contacts under supervision. Support information exchange.
• Experience and Education
• • First university degree (Bachelor level) in a relevant field if required by the function.• 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.
• Skills and competencies
• 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 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.
• Other requirements
• • 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…. ).
• DEI Statement
• 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 underrepresented in at DNDi and across the sector, especially women, and including, but not limited to, black and minority ethnic candidates, and those with other protected characteristic.