Rebacca Baldwin

Data Management Lead @精鼎医药

CA

Performed data management activities with focus on quality and study timelines as per study protocol.• Reviewed protocols and participated in the development of study related documents such as data management plan, data validation specification, eCRF Completion Guideline and data entry guidelines (CCG).• Prepared Study set-up documents like Mock Case Report Forms, Edit-check specification, CRF completion guidelines, Data Review plan, Third party protocol, Data Handling plan etc.• Contributed to the creation of Data transfer specifications (DTS), eCRF (Electronic Case Report Form) specification, Test Scripts and SAS listings.• Performed discrepancies management, vendor reconciliation, eCRF Listings review and generated queries for the discrepancies identified during the review.• Worked on various study setup, conduct and close out activities. Worked closely with RAVE and Inform developers on the design, testing (UAT) and implementation of clinical databases.• Worked on postproduction changes like drafting postproduction change requests and its implementation.• Performed UAT as per the test scripts and created edit check specifications (ECS), e CRF specification for database testing during start-up phase before Go Live.• Performed SAE and ECG reconciliation in a timely manner.• Monitored clinical data management project status using standardized status reports and customized reports.• Point of contact for development and testing of case report forms and edit checks from the library.• Updated Standard Operating Procedures (SOP’s), Data Management Plan as per requirements.• Establishing and maintaining project timelines, convening project team meetings, and communicating with stakeholders.• Ensuring the final database DM documents are complete and all data issues have been tracked, reviewed, reconciled, and resolved as per SOPs.