[Closing date: May 20, 2017]
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 seven 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 Africa was established in 2003 in Nairobi to ensure connection with our founding partner KEMRI and support clinical development programs. 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. 30 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.
In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research & Development Partnership (GARDP), a not-for-profit research and development initiative to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all. GARDP aims to have at least two projects that address urgent global health needs ready for implementation by the end of 2016, and two more by the end of 2017.
In this context of increasing activities and regionalization, DNDi has engaged a reorganization process which aims at effectively implementing the recently approved business plan, and is currently looking for a Senior Data Manager.
Purpose of the position
Ensure effective operation and implementation of the data management functions for clinical studies / trials.
Specific Job Responsibilities
- To develop study specific data management plans, and design, validate and maintain clinical trial databases.
- To work with appropriate project staff, to ensure that efficient and reliable data management systems are in place in the DNDi Data Centre.
- To contribute to the development of data management policies and strategies for the DNDi Data Centre.
- To ensure compliance with data management standards and best practices.
- Participate in the development, review and oversight of standard operating procedures (SOPs) for the DNDi Data Centre.
- To assist in setting up data management systems for the data center together with the implementation, review and monitoring of those systems.
- To design, set up and validate databases and data entry screens for clinical research projects and prepare the necessary documentation for this.
- To develop, write and test data range and inconsistency checks.
- To ensure that data queries are raised and resolved in a timely and accurate manner.
- To provide feedback and training to study teams regarding common data errors.
- To supervise, train data management officers and data entry staff.
- To provide input into Case Report Form (CRF) development.
- To contribute to the development of Standard Operating Procedures (SOPs) for the data team, in compliance with Good Clinical Practice (GCP).
- To coordinate data entry and other data management activities both at trial sites and DC (including Electronic Data Capture).
- To assist in developing effective systems and procedures for ensuring an efficient and reliable data management service in the DNDi Data Centre.
- To 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.
- Any other tasks as requested by the head of the DNDi Data Centre.
Skills and Attributes
- Strong 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.
- Strong communication skills in multicultural, multi-lingual environments.
- Well organized and structured.
- Strong analytical skills.
- Strategic thinking and leadership abilities.
- Has autonomy for taking actions and decisions.
- Lead and motivate a small team for optimum performance, supervising junior staff.
- Advanced knowledge of a statistical analysis package such as STATA.
- Advanced IT skills and working knowledge and proven experience of IT systems and programming in some language or software package will be an added advantage.
- Minimum 6 years’ relevant experience of which at least 3 years’ experience are data management in a clinical research environment.
- Extensive experience with data management systems (knowledge of OpenClinica will be an added advantage).
- Experience with Electronic Data Capture (EDC) systems.
- Experience working in clinical research with an understanding of GCP principles.
- Bachelor’s degree in Computer Science / IT / ICT or related discipline.
- Good working knowledge of Microsoft Excel and MS Access.
- Willingness and flexibility to travel as required.
- Deadline for application: Accepting applications until May 20th, 2017
- Only shortlisted candidates will be contacted.