Clinical Project Manager

Geneva, Switzerland

[Closing date: 31 August 2016]

Job Description

The Clinical Project Manager will play an important role in the development of new drugs and treatments for neglected diseases. S/he will be involved in the coordination, support and documentation of projects throughout all stages of the development process, with particular focus on the clinical phases. As a Clinical Project Manager s/he will report to the Head of Clinical Program in the DNDi R&D team; and to directly oversee the use of DNDi resources for given projects.

Specific job responsibilities

Develop project plans

  • To develop project protocol, project schedules and budgets with the Head of Clinical Program and the investigators
  • To monitor milestones for project evaluation with the Head of Clinical Program
  • To play a full role in the R&D team and to be an active member of the DNDi organization

Ensure regulatory compliance for projects

  • To be familiar with pharmaceutical regulatory requirements, documentation and processes for major international agencies
  • To ensure projects follow GCP and regulatory compliance and keep appropriate documentation
  • To participate in preparing regulatory documentation
  • To prepare and review clinical SOPs and other standard documents required for clinical trials
  • Contribute to set up and to review of DNDi systems related to clinical operations as appropriated

Manage and develop project reporting systems

  • To set up project management and data management systems, e.g., Microsoft Project to support R&D
  • To collect data and information to enable Head of Clinical Program/ Medical Director and the R&D Director to make effective and cost-efficient use of DNDi resources
  • To interact with study site teams on a regular basis to ensure that projects meet their milestones
  • To provide logistical support and tracking for all trial materials with the trial monitors, trial managers and site investigators.
  • To liaise with the project consultants and collaborators within the project network
  • To write a monthly project update, when requested

Enable review of projects

  • To provide progress reports to Head of Clinical Program and senior management members on individual projects including budget updates, on a regular basis
  • To assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

Personal

  • To develop and maintain the skills required for delivery of all aspects of clinical trials
  • To maintain an awareness of all developments in the designated neglected diseases that relate to drug development and disease control
  • To be aware of developments in clinical development and the regulatory environment, and report these to DNDi

 

Qualifications / Person specification

  • S/he will have high level scientific qualifications (MSc or PhD) in a relevant discipline with a proven record of organizational and IT skills.
  • S/he will also have high level interpersonal skills and an ability to interact in international research collaborations
  • At least 5 years experience in clinical R&D
  • The Clinical Project Manager will be based in Geneva and must be prepared for work related travel
  • Linguistic skills: English, French, additional language is an asset.

To apply

  • For additional information about DNDi please visit our website at www.dndi.org.
  • Accepting applications until 31st August 2016.
  • Only shortlisted candidates will be contacted