Clinical Project Manager

Geneva, Switzerland

[Closing date: 13 January 2016]

Link to the growth of activities and new Business Plan, DNDi is looking for a Clinical Project Manager who will play a leading role in the Clinical development of new drugs and treatments for neglected diseases (Sleeping Sickness area). He/she will be involved in the supervision, development and regulatory review of clinical trial projects. He/she will ensure the smooth running of clinical trials, according to Good Clinical Practice and other ICH Guidelines. He/she 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 Manager he/she will be expected to maintain frequent interaction with investigator’s teams and the DNDi Project team and to directly oversee the budget for his/her given studies.

He/she will work on neglected diseases in endemic countries for a new chemical entity.

He/she will report to the relevant Disease Head of Clinical Program.

Responsibilities

  • 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.

Main Tasks

Project Management

  • 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.

Qualifications Required

  • 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 very good knowledge of French
  • Position based in Geneva.

 

To apply

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 hr@dndi.org.

For the full position description and additional information about DNDi please visit our website at www.dndi.org

Accepting applications until 13th January 2016

Only shortlisted candidates will be contacted.