[Closing date: 15 July 2016]
Overall purpose of the job
– Coordinating the Mycetoma clinical trial based in Sudan sponsored by DNDi according to Good Clinical Practice (GCP) standards, according to the specific responsibilities set out below under the direction of the Clinical Trial Manager (CTM) and the Director of DNDi Africa Regional Office (ARO), Nairobi, Kenya.
– Reporting to the Clinical Trial Manager.
Main duties and responsibilities
- Take lead in mycetoma research study implementation and activities.
- Preparing clinical trial site for study readiness and relevant study documentation and training materials.
- Resolving issues identified during the monitoring visits.
- Provide backup, support and advice for trial monitors including co-monitoring and substitute monitoring as and when required.
- Prepare monthly report of trials activities and issues for DNDi Project Management and DSMB Chair.
- Provide backup for the CTM for Serious Adverse Events (SAE) reporting.
- Support and respond to requests from trial site team members and country 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 the Clinical Research Associate(s).
- Liaise with DNDi ARO Finance & Administration department, Data Management team for trial related activities as required.
- Perform other duties as may be assigned.
Skills & qualifications
- Medical Doctor. Postgraduate training would be an added advantage or equivalent clinical research supervision or management experience.
- Proven track record in clinical research management.
- At least 3 years recent experience of clinical trials and GCP as investigator/monitor /trial manager
- Complete fluency in written and spoken English. Knowledge of Arabic would be an added advantage
- 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’s mission and vision.
Terms of employment
Salary will be commensurate with skills and experience and in line with DNDi remuneration scales.
Contract is 2 years, renewable by mutual agreement and subject to exemplary performance, 3 months probation, notice period 1 month.
Applications are due not later than: 15th July 2016 and should be sent to:
HR & Administration Officer
DNDi Africa Regional Office
P.O. Box 21936-00505, Nairobi, Kenya
Applications should include the following:
- Letter of application supporting your candidature
- Current Curriculum Vitae listing names of three references with contact details (telephone and email)
- Your contact telephone number
Expected start date: Preferably immediate
Note: Local contract (no expatriate treatment)