[Closing date: 20 September 2015]
DNDi is looking for a Clinical Trial leader for HIV/HCV who will play a leading role in the Clinical development of new drugs and treatments for the 2 diseases. S/he will be involved in the supervision, development and regulatory review of clinical trial projects in East Asia for HCV and Africa for HIV. She/he will ensure the smooth running of Clinical Trials, according to Good Clinical Practice and other ICH Guidelines. She/he will maintain and generate documentation pertaining to the management of the trial and will manage Partners and Clinical Research Organizations to insure the above goals are obtained. As a Clinical Team Leader s/he will be expected to maintain frequent interaction with investigators, partners and project team and to directly oversee the DNDi budget for his/her given studies.
S/he will report to the HIV/HCV Program Leader.
- To coordinate all clinical trial related activities guaranteeing:
– the respect of the rights, the safety and the protection of the persons participating in the clinical trial
– the respect of the applicable regulations and recommendations, and of the Clinical Trial Protocol
– the accuracy, the veracity, completeness, consistency with the source data collected
- Compliance with the objectives, the planning, the timelines and the clinical trial budget.
- To supervise clinical trial managers based in Africa and Asia
- To work closely with the Team Leader on overall program planning and budgeting
- Planning, set-up and follow-up of the clinical trials,
- Follow-up of the clinical trial progress: monitor milestones, compliance with the deadlines, presentation meetings of the clinical trial progress to the project team
- Selection and follow-up of the subcontractors and partners during the clinical trial
- Management of clinical budgets and invoices
- Development of clinical trial tools
- Interaction with Data and Safety Monitoring Board Members
- Provide progress reports to Head of Disease Program on individual projects including budget updates on a regular basis.
Clinical Trial Documentation
- Finalize the development and secure approval of the clinical trial documents: Clinical Trial Protocol, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form…
- Coordination of the clinical trial documentation.
Clinical Trial Set-up
- Management of the clinical trial set-up:
administrative steps (e.g. submission to Competent Authorities and Ethics Committees…)
investigators’ selection and Investigators’ Meeting
coordination of the logistics (sending the Investigational Medicinal Products to the trial sites)
- Liaison with the CRAs/Trial Coordinator for appropriate trial site set-up
- Maintenance of the clinical trial documentation
Clinical Trial Follow-up and Clinical Trial Report
- Follow-up of the trial allocated budget
- Liaison with the CRAs for appropriate site monitoring
- Coordination of the clinical trial logistics (sending, return, destruction of the study supplies)
- Management of possible Clinical Trial Protocol Amendments, other follow-up issues and possible administrative steps (e.g. submissions to Competent Authorities and Ethics Committees) during the clinical trial
- Management of the Serious Adverse Events and other safety issues during the clinical trial
- Follow-up of the subcontracted data management and statistical activities
- Notification of the end of the clinical trial
- Coordination of the development of the Clinical Study Report and its appendices
- Maintenance of the clinical trial documentation.
- Degree in Scientific / Healthcare discipline
- Experience in clinical research (minimum 10 years)
- Knowledge in the applicable regulation for clinical trials and in Good Clinical Practices,
- Knowledge of HIV/HCV environment is a plus
- Ability to manage a team worldwide and to conduct meetings,
- Fluent in English
- Position based in Geneva with frequent travels in South East Asia and Africa
Please send via email only a letter explaining why you are applying for this post and an up-to-date copy of your CV/resume to email@example.com.
For the full position description and additional information about DNDi please visit our website at www.dndi.org
Accepting applications until 20th September 2015
Only shortlisted candidates will be contacted.