Major Accountabilities and Responsibilities
• Performing management activities to clinical trial start up, budget control, initiation, patient enrollment, protocol adherence, CRF compliance, data quality so that they meet specified ethical, scientific, regulatory needs. Developing and maintain KOL relationships.
• Maintains good communications and relationships with CRO partners, including but not limited to CRC, CRA, PM or DM if applicable.
• Responsible for tracking, distribution and filing of clinical trial documents/information with quality review for accuracy and completeness.
• Responsible for the clinical trial meets ICH – GCP guidelines, local regulatory requirements, protocol.
• Supports and coordinates the clinical trial application for amendment and progress report to ethics committee and regulatory authority, if applicable, and obtain approval within required timeline.
• Organizes appropriate training programs and project teleconferences as applicable.
• Maintains/develops local tracking spreadsheets for study-related documents, data, tasks and activities, as applicable.
• Bachelor degree in medical/biomedical discipline or equivalent
• At least 3-5 year’s clinical operation monitor experience
• Good English skills in writing and reading
• Knowledge of ICH GCP and local regulations
• Experience in management of clinical trial and/or regulatory documents
• Interpersonal communication skill