Clinical Data Manager
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18+ years experience leading and supporting cross-functional Clinical Data Management and Safety teams.
Strong knowledge of Bio/Pharmaceutical and Hospital/Healthcare industry best-practices and FDA/EMEA regulatory requirements; expertise in clinical development process, including SAE and External Data
Reconciliation, EDC database build, Stuvfdy conduct, Database lock, Investigator Meeting and CRA training,
Discrepancy Management and CRO Oversight, ICH-GCP guidelines and Patient Accounting.
Experience leading and supporting cross-functional Clinical Data Management and Safety teams.
Strong knowledge of Bio/Pharmaceutical and Hospital/Healthcare industry best-practices and FDA/EMEA regulatory requirements; expertise in clinical development process, including SAE and External Data
Reconciliation, EDC database build, Study conduct, Database lock, Investigator Meeting and CRA training,
Discrepancy Management and CRO Oversight, ICH-GCP guidelines and Patient Accounting.
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