Local Clinical Project Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from startup through to database lock and closeout activities. Further services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol company Standard Operating Procedures (SOPs) International Conference on Harmonization for Good Clinical Practice (ICHGCP) and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA) Site Manager (SM) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
Deliverables