职责描述：Performs the role of Local Clinical Project Manager (LCPM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in Genor Bio Medical Department procedural documents.
May perform the role of Global Clinical Project Manager (GCPM) for single country as described in Genor Bio Medical Department procedural documents.
LCPM is a person within Trial Co-ordination and CRA responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries.The LCPM is the primary point of contact at a country level for assigned studies.The LCPM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.
LCPM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants, CRA and LCPMs. The LCPM may have some site management responsibilities.
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