Clinical Project Manager – Maternity Cover

Geneva, Switzerland

[Closing date: 21 April 2016]

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. S/he will be involved in the supervision, development and regulatory review of clinical trial projects. 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 Organization to insure the above goals are obtained. As a Project Manager s/he will be expected to maintain frequent interaction with investigator’s teams and the DNDi Project team and to directly oversee the DNDi budget for his/her given studies.

  • S/he will work on neglected diseases in endemic countries for a new chemical entity.
  • S/he will report to the Head of HAT Clinical Program.
  • Short term contract of 9 months – maternity leave replacement

 

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 5 years)
  • Knowledge in the applicable regulation for clinical trials and in Good Clinical Practices
  • Ability to manage projects and to conduct meetings
  • French mother tongue or proficiency + Fluent in English

 

To apply

Short term contract from June 2016 to end of February 2017 for maternity leave replacement.

Position based in Geneva including 2 or 3 travels in 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 hr@dndi.org.

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

Accepting applications until April 21st 2016

Only shortlisted candidates will be contacted.