Started studies, maintained studies and closed studies.

Lead and assumed operational and/or oversight for all assigned internal and outsourced studies, and applied Data Management best practices.• Incorporated and maintained Bayer standards in clinical studies and projects for all elements of the medical standards package.• Documented all activities adequately for all assigned studies according to SOPs and took a lead role in QC activities, which included, but were not limited to: initiating the SDMD, maintaining document management systems, coordinating and ensuring contributions from relevant functions (i.e., EDC, CDC, etc.), requesting a timely QC of the SDMD, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.• Specified and developed study specific eCRFs, database structures and data consistency checks based on medical standards, the Clinical Study Protocol and input from the study team.• Prepared, tracked and implemented standard plans (i.e., GDM Study Plan, Data Management Plan, Operational Oversight Plan, etc.) and ensured proper governance of data management study set-up, conduct and closure activities.• Accounted for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of protocol deviations, planning and conduct of interim and final Validity Review Meeting.• Supported study data management and data cleaning processes on an ongoing basis, applied study specific documents and conventions.• Identified and issued queries, incorporated query replies, tracks query status.

Lead and assumed operational and/or oversight for all assigned internal and outsourced studies, and applied Data Management best practices.• Incorporated and maintained Bayer standards in clinical studies and projects for all elements of the medical standards package.• Documented all activities adequately for all assigned studies according to SOPs and took a lead role in QC activities, which included, but were not limited to: initiating the SDMD, maintaining document management systems, coordinating and ensuring contributions from relevant functions (i.e., EDC, CDC, etc.), requesting a timely QC of the SDMD, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.• Specified and developed study specific eCRFs, database structures and data consistency checks based on medical standards, the Clinical Study Protocol and input from the study team.• Prepared, tracked and implemented standard plans (i.e., GDM Study Plan, Data Management Plan, Operational Oversight Plan, etc.) and ensured proper governance of data management study set-up, conduct and closure activities.• Accounted for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of protocol deviations, planning and conduct of interim and final Validity Review Meeting.• Supported study data management and data cleaning processes on an ongoing basis, applied study specific documents and conventions.• Identified and issued queries, incorporated query replies, tracks query status.

Involved in study start up, maintenance and close.Writes edit checks, DMP, eCRF completion guidelines, runs reports etc.

Cleans laboratory data and reconciles lab data with eCRF data.Performs user acceptance testing (UAT).Prepares Data Management Plans (DMP).Prepares data transfer agreements ((DTA) with laboratories.Reviews clinical data.Participates in Lab Edit check development and writing.Manages and maintains user list and site list in the database.Participates in in Protocol review and eCRF development.Generates manual queries, perform edit checks, and run reports; review and enter Local Lab Normal.Generate Data listings, Reports