Gabriela Milcheva Email & Phone Number

Sofia, Sofia City, Bulgaria

POSITION SUMMARY:Ensures the successful and accurate transfer of clinical trial data from laboratories and other clinical data providers to a Clinical Data Management System (CDMS) or other data repository. Receives electronic data files containing clinical trial data from external data provider and conducts data preparation steps to ensure the data is ready for processing. Loads processed data into CDMS or other data repository. Troubleshoots data load and processing errors and liaises… Show more POSITION SUMMARY:Ensures the successful and accurate transfer of clinical trial data from laboratories and other clinical data providers to a Clinical Data Management System (CDMS) or other data repository. Receives electronic data files containing clinical trial data from external data provider and conducts data preparation steps to ensure the data is ready for processing. Loads processed data into CDMS or other data repository. Troubleshoots data load and processing errors and liaises with study teams and data providers to resolve issues. Serves as the point of contact for electronic data inquiries from data providers and study teams.ROLE RESPONSIBILITIES:• Acts as primary point of contact for study teams and clinical data providers as it relates to the acquisition and processing of external clinical trial data• Liaises with study teams and clinical data providers to establish and communicate data standards and file format requirements• Processes electronic clinical trial data files and loads data into the CDMS (eg – Oracle Clinical, Medidata Rave) or applicable data repository • Troubleshoot data processing and data load errors and liaise with study team or clinical data provider to resolve issues• Develops the study specific Pharmacokinetic (PK) definition file template according to the study specification and sends the PK definition file template to the central lab after performing the required quality control checks Show less

Bulgaria

POSITION SUMMARY: Responsible for facilitating and meeting the support needs for the client(s) as they relate to the clinical trial management applications used, directly or indirectly, and for collecting, maintaining, and managing study data. Responsibilities: * Enters data and/or resolves issues related to user requests for clinical trial registry systems * Supports new processes, streamlining work, clean-up and data quality activities, and business transitions… Show more POSITION SUMMARY: Responsible for facilitating and meeting the support needs for the client(s) as they relate to the clinical trial management applications used, directly or indirectly, and for collecting, maintaining, and managing study data. Responsibilities: * Enters data and/or resolves issues related to user requests for clinical trial registry systems * Supports new processes, streamlining work, clean-up and data quality activities, and business transitions * Creates and maintains Drug Program data * Creates and maintains Investigator records * Advocates and supports established Registry related business processes * Creates and issues Data Compliance reports on a weekly basis Show less

Bulgaria