Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.
DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception, DNDi has developed eight new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.
DNDi East Africa was established in 2003 in Nairobi to ensure connection with our founding partner KEMRI and support clinical development programmes. This DNDi regional office conducts R&D projects in the Eastern Africa region (esp. Kenya, Uganda, Sudan, Ethiopia, Tanzania), including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, mycetoma and others. It also leads capacity strengthening initiatives through multi-country research platforms with the objective to ensure sustainable R&D capacities for DNDi projects. The team has grown to approx. 35 people today. As part of the global strategy, DNDi is further empowering its regional teams to ensure a coherent regional development across disease areas and activities, while reinforcing coherence among disease clusters.
Purpose of the position
This position will coordinate data entry and other data management activities providing Data Management and Biostatistics support through designing, setting up of data management systems, and validating databases for clinical studies and in the preparation of the necessary clinical data related documentation.
Specific job responsibilities
- Assist in setting up data management systems for the DNDi Data Management and Biostatistics department, together with the implementation, review, and monitoring of the systems
- Design, set up, and validate databases and data entry screens for clinical research projects, and prepare the necessary documentation
- Develop, write, test, and validate inbuilt data inconsistency checks
- Ensure that data queries are raised and resolved in a timely and accurate manner
- Ensure data management quality control procedures are done in a timely and accurate manner
- Provide feedback and training to study teams regarding common data errors
- Supervise, train data management officers and data entry staff
- Take lead in Case Report Form (CRF) development
- Contribute to the development of SOPs for the data team, in compliance with Good Clinical Practice (GCP)
- Coordinate data entry and other data management activities both at trial sites and the Data Management and Biostatistics department (including Electronic Data Capture)
- Assist in developing effective systems and procedures for ensuring an efficient and reliable data management service in DNDi Data Management and Biostatistics department
- Participate in efforts geared towards improving the effectiveness and efficiency of operations in accordance with the policies and procedures as laid down in the organization’s quality manual
- S/he reports to the Data Operations Manager
- Close working relationship with the relevant members of the DNDi East Africa regional office in Nairobi and DNDi global disease teams
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
- Minimum 6 years’ relevant experience with at least 3 years data management experience in a clinical research environment
- Proven ability to work effectively in a team environment and matrix structure
- Experience working with Electronic Data Capture (EDC) systems
- Graduate or post graduate degree in computer science/ICT/IT or relevant field
- Fluency in English and French
- Travel up to 25%
- Please submit your application using the online form
- Deadline for application: Accepting applications until 28 February 2021
- Only shortlisted candidates will be contacted
- Application submission for this position may close early if we have enough suitable applicants