Experience

eClinical Solutions

• United States
• Software Development
• 300 - 400 Employee

• QC Specialist

  • May 2015 - Present



Baxter International Inc.

• contracter with baxter

• Clinical Data Operator

  • Feb 2014 - Apr 2015

  Oracle eClinical IMedidata Data entry Edit check testing Database testing DCF creation QC Coding Oracle eClinical IMedidata Data entry Edit check testing Database testing DCF creation QC Coding



EMD Serono, Inc.

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Clinical Data Operator

  • Sep 2010 - Mar 2013

  Coordinate & Perform QC of DM documentation, CRFs/DCFs or PDF files versus database. Test data entry screens for new studies to ensure proper data processing Assist with edit check testing as needed. Review all DM documentations prior to filing in TMF. Coordinate and perform QC of DM sections of the Trial Master File. Run listings to QC output of test data, labels and codes for paper and EDC trials. Maintain documentation of the testing for each trial. Create and review… Show more Coordinate & Perform QC of DM documentation, CRFs/DCFs or PDF files versus database. Test data entry screens for new studies to ensure proper data processing Assist with edit check testing as needed. Review all DM documentations prior to filing in TMF. Coordinate and perform QC of DM sections of the Trial Master File. Run listings to QC output of test data, labels and codes for paper and EDC trials. Maintain documentation of the testing for each trial. Create and review data listings. Freeze/unfreeze specific eCRF screens (for EDC process) Supervise and train CDOs and Senior CDOs as needed Work with Director of Data Management and other Data Management line managers in resource allocation and prioritization to meet project timelines. Prepare data entry guidelines for new studies in conjunction with Data Analysts. Ensure DEGs are updated and document all changes as needed in conjunction with Data Analysts and staff supplied with latest version. Correct data discrepancies found during the verification process. Receive CRFs from CTLs, CRAs or sites. Inventory and reconcile data received vs. CRF Inventory Log Track date of receipt and data entry of CRFs & DCFs in computerized tracking system. Filing and splitting of CRFs; as needed. Data entry of clinical data, as needed. Communicate trends in data errors and inconsistencies to Data Analysts and CDO staff. Provide feedback to Data Analysts regarding entry/verification status, quality of data entry and quality of data recorded on CRFs. Run status reports from tracking for each study to help evaluate workload. Organize and maintain file system for CRFs, DCFs and DE documentation in the Data Management Department Produce data listings for QC verification and audits Perform QC of CRF/DCF data vs database Perform QC of PDF files for EDC Archive Files of CRFs and DCFs and ship to offsite storage facility. Understand and follow Data Entry SOPs and Working Conventions Show less Coordinate & Perform QC of DM documentation, CRFs/DCFs or PDF files versus database. Test data entry screens for new studies to ensure proper data processing Assist with edit check testing as needed. Review all DM documentations prior to filing in TMF. Coordinate and perform QC of DM sections of the Trial Master File. Run listings to QC output of test data, labels and codes for paper and EDC trials. Maintain documentation of the testing for each trial. Create and review… Show more Coordinate & Perform QC of DM documentation, CRFs/DCFs or PDF files versus database. Test data entry screens for new studies to ensure proper data processing Assist with edit check testing as needed. Review all DM documentations prior to filing in TMF. Coordinate and perform QC of DM sections of the Trial Master File. Run listings to QC output of test data, labels and codes for paper and EDC trials. Maintain documentation of the testing for each trial. Create and review data listings. Freeze/unfreeze specific eCRF screens (for EDC process) Supervise and train CDOs and Senior CDOs as needed Work with Director of Data Management and other Data Management line managers in resource allocation and prioritization to meet project timelines. Prepare data entry guidelines for new studies in conjunction with Data Analysts. Ensure DEGs are updated and document all changes as needed in conjunction with Data Analysts and staff supplied with latest version. Correct data discrepancies found during the verification process. Receive CRFs from CTLs, CRAs or sites. Inventory and reconcile data received vs. CRF Inventory Log Track date of receipt and data entry of CRFs & DCFs in computerized tracking system. Filing and splitting of CRFs; as needed. Data entry of clinical data, as needed. Communicate trends in data errors and inconsistencies to Data Analysts and CDO staff. Provide feedback to Data Analysts regarding entry/verification status, quality of data entry and quality of data recorded on CRFs. Run status reports from tracking for each study to help evaluate workload. Organize and maintain file system for CRFs, DCFs and DE documentation in the Data Management Department Produce data listings for QC verification and audits Perform QC of CRF/DCF data vs database Perform QC of PDF files for EDC Archive Files of CRFs and DCFs and ship to offsite storage facility. Understand and follow Data Entry SOPs and Working Conventions Show less



EMD Serono, Rockland, MA

• Senior Clinical Data Operator

  • Jun 2010 - Sep 2010

• Data and QC Coordinator

  • Jan 2007 - Jun 2010