Senior TMF Officer

The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases affecting millions of the world’s poorest people. 

Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients. 

13 new treatments for people with Sleeping Sickness, Visceral Leishmaniasis, Chagas disease, HIV, Hepatitis C, and Malaria that have saved millions of lives. We aim to deliver a total of 25 new treatments by 2028 – addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID-19) and climate-sensitive diseases (such as Dengue) with a focus on the needs of patients in low- and middle-income countries.

With more than 240 employees of 30+ nationalities located in nine offices on four continents, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply.

The R&D organisation drives therapeutic innovation from the lab bench to the patient bedside.  it develops DNDi’s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients’ access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi’s virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICS clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDI functions, beyond R&D. 

The R&D organisation includes three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases.  Medical Affairs (Pharmacovigilance, Clinical Quality and Assurance, Regulatory and Translational Sciences), Global Clinical Operations, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review; Science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organisation for all other topics.   

The Trial Master File Management Senior 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 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 is ultimately responsible to ensure inspection readiness for the TMF across all Disease Programme/Cluster. This position provides guidance and may supervise TMF Officers.

• to foster DNDi’s institutional development in the Indian sub-continent to profile and position DNDi as a trusted R&D and health partner in India and the South Asia region.
• to identify local opportunities aligned with DNDi mission, vision, strategy, and priorities and engage partners and stakeholders in DNDi projects and model.
• to foster relationships and alliance with public and private actors in the field of R&D and public health
• to develop funding resources by implementing strategies connecting public investments in R&D (and access) and private contributions.
• to ensure collaboration across offices and teams
• to represent our partner Foundation, GARDP, and nurture collaborations on antimicrobial resistance (AMR)
• To ensure compliance of the legal entities and being a director on the board.

Interactions

• Works with all teams, and all units in all departments
• Collaborators, counterparts, and service providers are mainly in the functional area in and outside DNDi to get information, guidance, and feedback or to enlist cooperation.
• Works on the organization of representation of DNDi at smaller events and with external stakeholders of same equivalent level

• Create a TMF Index in collaboration with Quality department
• 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, classification and legibility)
• Archive clinical trial documents within Veeva system
• Manage the user administration and conduct training of the Trial Master File/eTMF master file process in Veeva
• 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
• Act as the Subject Matter Expert for the Trial Master File process, ensuring that project documentation is maintained to the highest level of quality and compliance while aligning with company and departmental objectives
• 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
• Support and supervise the team of TMF officers.

Additional /specific/projects responsibilities

eTMF:

• Collaboration with IST business partner to create and update reports and dashboard and also select, test and adopt new functionalities
• Liaise with Veeva Service Management to improve the system, validate and implement in the production environment
• Impact assessment on every new Veeva release
• CTMS
• Collaboration with IST business partner to create and update reports and dashboard and also select, test and adopt new functionalities
• Liaise with Veeva Service Management to improve the system, validate and implement in the production environment
• Impact assessment on every new Veeva release.

The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade. This job description may be subject to review.

Reporting line

• Senior TMF Officer reports to Clinical Operations representative 

Interactions

• Works with all teams, and all units in the all departments

Collaborators, counterparts, and service providers are mainly in the functional area in and outside DNDi to get information, guidance, and feedback or to enlist cooperation. Works on the organization of representation of DNDi at smaller events and with external stakeholders of same equivalent level

• Minimum 6 years’ work experience in Clinical Trials and Clinical Operations or equivalent
• Proven ability to work effectively in a team environment and matrix structure
• Experience of working in the public and private sectors is highly desirable.
• Graduate or post graduate degree in clinical research or equivalent
• Formal training or certification as required by the function

• 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
• Very Good communication skills in multicultural, multi-lingual environments
• Ability to work effectively as part of a multicultural team
• Well organized and structured
• Very good analytical skills
• Ability to contribute to the project delivery under minimum supervision
• Ability to manage middle sized projects with budget management under supervision
• 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
• Ability to interact with external stakeholders
• Ability to be the focal point/manager for consultants
• Ability to supervise at a smaller level
• Very good Knowledge of regulatory (GCP, GLP and GMP) particularly in TMF management
• Very strong technical writing skills (procedures, protocols and reports)

• Fluency in English
• Proficiency in local languages desirable (French)
• Good 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 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.