- Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
- Accountable for the oversight of IST/ISS granted by Merck, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
- Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
- Develop and monitor study budget and timelines
- Monitor work to ensure quality
- Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
- Contribute to the planning and set-up of a study and provide planning parameters, Support early access programs on the country level
- Manages the budget for all local clinical studies and Global Phase IV studies assigned, as well as the IST/ISS grants.
- CRO > 5 yrs.
- Clinical Research > 5 yrs.
- Trial management > 5 yrs.
- Work with external CRO – nice to have
- Pharmaceutical industry – nice to have
Project start: July 2018
Availability: 5 days/week,
100% on-site support