[Closing date: 15 February 2019]
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 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
The Clinical Trial Assistant will offer the much-needed assistance to clinical trial teams including visceral leishmaniasis, mycetoma, and paediatric HIV in the course of the studies. S/he will mainly be concerned with management of the Trial Master File (TMF).
Specific job responsibilities
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of Trial Master file (TMF) for completeness.
- Assist clinical trial team in ethics and regulatory submissions.
- Assist clinical team with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
- Handle any other tasks as assigned
- 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
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 small projects if delegated by upper levels with supervision
- Minimum of 3 years’ experience in clinical trials
- Proven ability to work effectively in a team environment and matrix structure
- Experience working with investigator site files/TMF/Regulatory submissions is desirable
- Diploma/Degree in health-related field.
- Knowledge of GCP/ICH
- Deadline for application: Accepting applications until 15 February 2019
- Only shortlisted candidates will be contacted