Clinical Data Manager
SciClone Pharmaceuticals, Inc
09.2020 - Current
- Oversee the activities of CRO Data Managers form study start-up to database lock
- Create and reviewed the Data Transfer Specification in collaboration with the Programming team and vendor's programmers
- Generate reports for manual reconciliation or cross panel between AE and medical history, AE end of treatment page and AE drug administration record
- Perform a side-by -side reconciliation between the EDC database and Safety database for SAE reconciliation to ensure consistency and accuracy
- Review Protocol Deviation Reports to make sure that protocol deviation is collected according to the procedure by reviewing PD listings
- Review medical history forms for any ongoing medical history for corresponding con-med for such medical history events
- Perform coding review by running coding reports to make sure all verbatim terms are coded according to MedDRA and WHODrug dictionaries
- Perform in-house review of CRF for adherence to protocol requirements and project specific requirements
- Review the weekly listings from CRO DMs to monitor the activities of the CRO DMs
- Scheduled data management and data review meetings to resolve every data issue
- Perform Data management task from Study start-up to database lock
- Ensure compliance with appropriate sponsor SOPs
- Participate in clinical meetings with Sponsor as required
- Perform UAT of database using scripts and edit checks
- Attended meetings with Database Vendors on a consistent basis to address Clinical Team's requests and eCRF development activities
- Performed quality control checks of eCRFs and Study Service Request documents for GCP and FDA inspection readiness
- Used RECIST criteria for oncology studies
- Archived all the final study documentations which includes final protocol, the annotated CRF, DMP components, all the conventions, etc., in ETMF (Electronic Trial Master File) using Veeva Vault
- Maintained all necessary documentation to support the accuracy of the clinical trial database
- Perform interim analysis according to the protocol for safety and efficacy analysis
- Review and summarized the metric reports / study status reports sent by CRO and presented it to the in-house DMs for their reviews and comments
- Designed and prepared weekly study metrics and ad hoc reports for CTT meetings
- Monitor discrepancy management to ensure appropriate quality of data by regular checks during study conduct
- Participate in quality assurance reviews to verify accuracy and reliability of data
- Participate in external data reconciliation
- Delegated and collaborated with data managers on database cleaning process
- Monitor discrepancy management to ensure appropriate quality of data by regular checks during study conduct
- Participate in data management activities for interim analysis according to protocol for safety and efficacy analysis
- Created and reviewed data transfer specification
- Perform external data reconciliation.
