We have an opening for a clinical trial manager to support development projects in phases I-III.
The role will focus on management and supervision of all processes and tasks related to clinical trials management, management of 3 rd parties suppliers and reporting all findings and results in compliant manner.
Manage, implement, coordinate, and supervise all processes needed for clinical trial start-up, trial conduct and trial close-out from Sponsor’s perspective
Support trial centre and patient recruitment, take care of the cooperation with the trial centres being their central Sponsor contact person throughout the entire project
Contract management with trial centres and CROs as well as other external service providers
Supervise CRO and other external service providers performance with respect to implemented processes, quality, timelines, milestones and costs
Track and supervise trial budget and data quality
Data preparation and responsibility for the trail documentation and support the creation of presentations, trial documents and publications
Support audits at trial centres and external service providers
Work closely with internal functions such as medical affairs, regulatory affairs, pharmacovigilance, pharmacokinetics and external service providers (e.g., data management, statistics, monitoring, central laboratories)
University degree or experience in a medical profession such as Nurse
Knowledge of clinical trials management and operations
Prior experience in planning and conducting international clinical trials, preferably as Clinical Trial Manager, Project Manager or in a comparable position
Familiar with applicable local and international law and guidelines (e.g., ICH-GCP)
Familiar with EDC systems
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.