Description
Providing functional leadership and systems-related expertise, support and development for all aspects of Clinical Study Administration.Having accountability for the generation and maintenance of Study Documentation, and the management of the Document Store.
Working cross functionally within the Clinical Research Group to provide resources to productively deliver Clinical Study Administration activity for global, local and GSMO-led studies.
Leading the team of Study Delivery Administrators (SDAs), which may be comprised of staff and/or CRO employed staff
Providing systems-related expertise and support to CRG as required
Providing financial management expertise and support to CRG as required
Providing reports of Business Performance and Compliance for CRG as required
Ensuring close collaboration with Project Management and the other functional leads within CRG
Co-ordinating the Serious Adverse Event Management mailbox
Co-ordinating the administration of Study Feasibility process
Co-ordinating the administration of the Zinc process for Investigator meeting approval
Managing suppliers as required to provide services to the Clinical Research Group.