Geneva, Switzerland and Asia
[Closing date: 31 August 2015]
Linked to the growth of activities and new Business Plan, DNDi is looking for Clinical Project Managers who will play a leading role in the Clinical development of new drugs and treatments for neglected diseases (HIV, HCV, Sleeping Sickness etc). They will be involved in the supervision, development and regulatory review of clinical trial projects. They will ensure the smooth running of Clinical Trials, according to Good Clinical Practice and other ICH Guidelines. They will maintain and generate documentation pertaining to the management of the trial and will manage Partners and Clinical Research Organization to insure the above goals are obtained. As a Project Managers they will be expected to maintain frequent interaction with investigator’s teams and the DNDi Project team and to directly oversee the DNDi budget for their given studies.
They will work on neglected diseases in endemic countries for a new chemical entity.
They will report to the relevant Disease Head of Clinical Program.
- 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.
- Planning, set-up and follow-up of the clinical trials,
- Follow-up of the clinical trial progress: monitor milestones, compliance with the recording deadlines, presentation meeting of the clinical trial progress to the project team
- Follow-up of the subcontractors and partners during the clinical trial
- Management of clinical budgets and invoices
- Development of clinical trial tools
- Selection and validation of the 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 Design
- Management of the feasibility trial
- Coordination of the development and 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 7 years),
- Knowledge in the applicable regulation for clinical trials and in Good Clinical Practices,
- Ability to manage projects and to conduct meetings,
- Fluent in English and good knowledge of French
- Positions based in Geneva and Asia.
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 31st August 2015
Only shortlisted candidates will be contacted.