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 that affect 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.
Since our inception, DNDi has delivered twelve new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We now aim to deliver an additional 15-18 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.
The R&D organization 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 low- and middle-income countries (LMIC) 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 organization include three clusters of Diseases expert teams: Neglected Tropical Disease (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, R&D Portfolio and Planning, 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 organization for all other topics.
Counting the Malaysia Ministry of Health as a founding member, DNDi was established in Kuala Lumpur in 2004. An integral part of DNDi’s global network, DNDi South-East Asia develops and supports R&D and access partnerships in the broad region, including for hepatitis C and dengue, while contributing to the global strategy. The successful registration of ravidasvir in 2021 as the first affordable hepatitis C treatment paved the way for further collaborations in Malaysia, Thailand, and beyond.
With 250 employees of 37 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.
Purpose of the position
The TMF Officer is responsible to compile, maintain and archive all Trial Master File (TMF) and Clinical Trial Management System (CTMS) related documents in VEEVA to prepare the submissions to any international authorities and to comply with Good Clinical Practice (GCP) requirements for filing and archiving of clinical trials. The position holder will plan and coordinates the overall management of the Trial Master Files and associated processes following GCP and International Conference on Harmonization (ICH), including system and tool development, business process documentation and is ultimately responsible to ensure inspection readiness for the TMF across the initiative.
The TMF Officer has a key role in managing the time schedules for DNDi projects and directly supports Project Leader, Project Manager, and other stakeholders with various planning, forecasting, and reporting tasks. The position holder makes sure the schedule is at all times updated, maintained, analyzed and that it is communicated properly to relevant stakeholders. The position holder creates scenarios for project optimization, risk analysis/mitigation, takes baselines, makes reports and creates visualizations and proposals to enforce important decision making. The position holder will provide project planning, resource planning, support financial and budget planning, support cross-functional initiatives, including system and tool development, timeline template standardization, business process documentation and is ultimately responsible to ensure the accuracy of project plans according with project objectives across the initiative.
Specific job responsibilities
- Create a TMF Index in collaboration with Quality department
- CTMS: Put in place, adapt, provide training to users all over the implementation
- VEEVA: adapt workflows, e-signature, index, reporting, document management to DNDi needs
- 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)
- Archive clinical trial documents
- Manage the user administration and conduct training of the Trial Master File/eTrial master file process
- 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
- Developing project time schedules using MS Project and other planning tools
- Preparing scenario planning to evaluate potential options
- Create project baselines, analyzing schedules, and providing scenario plans for mitigation
- Maintaining the accuracy of project plans according with project objectives
- Analyzing the schedule variance, risk and opportunity
- Support resource and financial estimation for projects
- Preparing and presenting data to influence decision making
- Coordinating with project team to accelerate tasks and resolve problems
- Supporting the Project Portfolio analysis with inputs from selected projects
- Compile and provide routine standard reports on a monthly and ad hoc basis. Proactively address conflicting, incorrect, insufficient, or inappropriate information prior to report publication.
- Collect and analyse project and process data and metrics. Apply advanced project management tools for metrics collection and conduct advanced analysis of project data. Develop guidelines and checklists.
- Provide general training support, administration and guidance regarding project management practices and systems.
- Assesses performance against plans, processes, and practices to determine effectiveness and recommend areas for process improvement to Leaders and Managers within DNDi.
- Giving feedback to the line organization on learnings and best practices
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.
- The position holder reports to R&D Portfolio and Planning Leader
- Works with the Project Leaders, Project Managers, other key stakeholders from R&D and transversal organization
- 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
Skills and attributes
- 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 to 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
- Self-directed and work well in a team environment, can work on multiple projects concurrently and meet commitments, possess excellent oral and written communication skills, is process-oriented, converts goals to tasks and defines estimates on time and requirements to achieve goal objectives, and demonstrate initiative.
- Proficient technology skills in MS project and other planning tools and systems
R&D technical skills
- Very good knowledge of regulatory (GCP, GLP and GMP) particularly in TMF management
- Very strong technical writing skills (procedures, protocols and reports)
- Very good understanding of pharmaceutical development timeline for early and late-stage projects
- Experience: Minimum 6 years ‘work experience in TMF and CTMS management ideally in a health-related or non-governmental organization/institution
- Experience: Minimum 6 years extensive VEEVA use
- Capacity to adapt VEEVA workflows, e-signature, index, reporting, document management to DNDi needs
- Provide VEEVA training and support to users
- Proven ability to work effectively in a team environment and matrix structure
- Experience of working in public and private sector is highly desirable
- Graduate or post graduate degree
- Preferably a Malaysian
- Fluency in English
- Proficiency in local languages desirable
- Very good ability with IT tools
- Status: Fixed term contract of 1 year – may be renewable
- Please submit your application using the online form
- Deadline for application: Accepting applications until 15 December 2022.
- Only shortlisted candidates will be contacted.
- This position might close early if we have filled the position.