[Closing date: April 20, 2017]
The Drugs for Neglected Diseases initiative (DNDi) is a patient-needs driven, not-for-profit research and development (R&D) organization that develops safe, effective, and affordable medicines for neglected diseases that afflict millions of the world’s poorest people. DNDi focuses on developing new treatments for the most neglected patients suffering from diseases such as sleeping sickness (or human African trypanosomiasis), leishmaniasis, Chagas disease, specific filarial infections, paediatric HIV and Mycetoma. The initiative’s primary objective is to deliver 12 to 18 new treatments by 2023 and to establish a strong R&D portfolio for these diseases.
DNDi accomplishes its work through collaborative partnerships with public sector research institutions, particularly in disease-endemic countries, pharmaceutical and biotechnology companies, academia, non-governmental organizations, and governments worldwide. It also works to strengthen research capacity in disease-endemic countries and to advocate for increased public responsibility for neglected disease R&D.
DNDi was established in 2003 by the Kenya Medical Research Institute (KEMRI), the Indian Council for Medical Research (ICMR), Brazil’s Oswaldo Cruz Foundation (Fiocruz), the Ministry of Health of Malaysia, Institut Pasteur in France, and Médecins Sans Frontières/Doctors Without Borders (MSF), with the WHO Special Programme for Research and Training in Tropical Diseases (TDR) as permanent observer.
DNDi Africa Regional Office (DNDi ARO) was established in 2005, and is based at the Tetezi Towers in Nairobi,Kenya. This regional office conducts R&D projects in the region, including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, and Mycetoma. It also leads capacity building projects through multi-country research platforms.
DNDi ARO is seeking to recruit suitable candidates for the following vacant positions
Overall purpose of the job:
- Coordinating the PKDL (post-kala-azar dermal leishmaniasis) clinical trials and studies sponsored by DNDi according to Good Clinical Practice (GCP) standards, according to the specific responsibilities set out below under the direction of the and Clinical Trial Manager (CTM)
Main duties and responsibilities
- Take lead in PKDL research study implementation and activities
- Preparing clinical trials sites for study readiness and relevant study documentation and training materials.
- Acting as primary clinical monitor for the designated PKDL clinical trial
- Identifying and resolving issues identified during the monitoring visits.
- Prepare monthly report of trials activities and issues for DNDi Project Management in Geneva / trial coordination office.
- provide backup for the clinical trial manager for Serious Adverse Events (SAE) reporting
- Support and respond to requests from trial site team members and PIs on trial related matters
- Arrange trial specific and non-specific training for trial site teams to enhance overall quality of study and recruitment of study participants
- To participate in preparing regulatory documentation for conducting clinical trials (submission and approval of protocols) and registration of trial medication
- Supervise other Clinical Research Associate(s) designated for the trial
- Liaise with DNDi ARO Administration & Finance department, Data Management team for trial related activities as required
- Oversees and follow-up on corrective action plans for the GCLP lab initiative at the LEAP sites
- Perform other duties as may be assigned
Skills & Qualifications
- Postgraduate training or equivalent would be an added advantage
- Clinical Research Supervision or management experience.
- Laboratory experience, especially in quality assurance and control
- Medical Doctor preferable.
- Proven track record in clinical research management.
- At least five years’ recent experience of clinical trials and GCP as investigator/monitor /trial coordinator
- Complete fluency in written and spoken English
- Able to work under minimal supervision, in an organized and professional manner and with financial integrity
- Good interpersonal, people and time management skills
- Problem solving and helpful approach
- Willingness and flexibility to travel as required
- Shares DNDi mission and vision.
Terms of Employment
- Salary will be commensurate with skills and experience and in line with DNDi remuneration scales.
- Contract is two years, renewable by mutual agreement and subject to exemplary performance, 3 months’ probation, notice period 2 months.
- Deadline for application: Accepting applications until April 20, 2017.
- Only shortlisted candidates will be contacted.