[Closing date: 13 September 2015]
DNDi has several clinical projects in the pipeline for Visceral Leishmaniasis (VL), including phase II and phase III clinical trials, pharmacovigilance studies, and possibly new candidates transitioning for clinical development. Contributing to the development of new treatments for VL, the Project Coordinator will be involved in the coordination, support and documentation of R&D projects throughout all stages of the development process, with particular focus on the clinical phases. As a member of the DNDi R&D team, s/he will report to the Head of Leishmaniasis program and Leishmaniasis Project Manager in the R&D team and directly oversee the use of DNDi resources for given projects.
Specific job responsibilities
Ensure regulatory compliance for projects
- To be responsible for the designated project-related clinical development documentation and be familiar with pharmaceutical regulatory requirements, documentation and processes for major regulatory agencies with a view to the eventual registration of the new treatment.
- To ensure the projects follow international GCP, DNDi SOPs and other relevant regulations, and keep and organize the documentation to that end
Development and Planning of new clinical trials
- To support the Project Manager on the development of study related materials such as the study protocol, informed consent form, study specific procedures, study forms and tools.
- To participate in the selection process of clinical study sites, identification of needs, preparation of sites, planning for the study implementation, development of recruitment strategies, etc.
Develop project plans and monitor their implementation
- To interact with all project partners on a regular basis to track activities and progress, and identify in a timely manner problems or deviations from the project schedule that need to be addressed.
- To monitor milestones for project evaluation with the Head of VL Clinical Program and prepare monthly reports.
Manage and develop project reporting systems
- To update project management systems e.g. SharePoint, and track the progress of the projects.
- To provide logistical and administrative support and tracking for all trial materials with the trial monitors, trial managers and site investigators.
- To provide administrative support to the for the organization of team meetings and minutes
Qualifications / Person specification
- Scientific qualifications (MSc, PhD) in a relevant biomedical discipline, with experience in pharmaceutical R&D, including at least 5 years in clinical development
- Familiar with European Pharmacovigilance regulations
- Fluency in written and spoken English,
- Excellent interpersonal skills, leadership qualities and an ability/track record of working in a multicultural collaborative research environment, with international external groups
- Ability to work independently and drive initiatives to improve project performance
- Proven organizational and IT skills
- The Project Coordinator will be based in Geneva and will be expected to travel to VL endemic countries (e.g. Sudan, Ethiopia, Kenya, Uganda, India, Bangladesh)
- Very committed to the mission and vision of DNDi
- 9 months Contract
- Please send via email a letter explaining why you are applying for this post and an up-to-date copy of your CV/resume to firstname.lastname@example.org.
- For the full position description and additional information about DNDi please visit our website at www.dndi.org
- Accepting applications until 13th September 2015
- Only shortlisted candidates will be contacted.