The Clinical Trial Manager is responsible for the regional / global coordination of clinical trial management activities for internally managed and / or outsourced trials.
Responsibilities also include management of global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners.
This position leads the Study Management Team (SMT) and interfaces with stakeholders internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and Study Sites (if applicable).
He / she works closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. Can contribute to taskforces and provide innovative input.
Major Duties & Responsibilities
Ensure regional / global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT).
This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL.
Support GTL in leading related CRO country & site activities.