[Closing date: 31 August 2016]
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
- 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.
- 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