Position Summary
The Clinical Development Associate (CDA) contributes to Study Delivery with appropriate quality by having primary responsibility for essential document management and coordinate tasks that improve team performance from a wider perspective during the study process.
Principal Responsibilities
Trial Master File (TMF) Management Initiate and lead the set up of TMF including tracking of documents.
Implement of appropriate quality check of the study-related documents in TMF and check GCP and SOP compliance.Check the status of document storage (Completeness, Timeliness) and share the information to study team.Coordination of Clinical Trial Notification (CTN)Set a schedule of necessary actions for CTN submissionCoordinate information collection for CTN and draft it and manage timing of CTN update for regulatory compliance.JNDA/InspectionPrepare index/documents required sub...