Clinical Data Management Specialist

• To assist the Lead DM to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing
• With guidance from more experienced staff, develop and implement project plans and technical specifications for relevant Data Management tasks in project scope, to document any changes to the Data Management project plans and communicate to the Project Team
• Provide input, assistance and/or oversight with preparation of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification
• Support the Lead DM performing the user acceptance testing (UAT) during the initial EDC setup, database migrations and study relevant supporting systems
• Assist with and/or oversee the creation of test data for entry screens and edit checks. Prepare and updаtеof study reports and metrics as required
• Participate in the SAE reconciliation process and follow up with the internal teams
• Manage EDC access request and documentation
• Coordinate the study team training assignments via respective internal training system.
• To support the Project Manager with the coordination and the implementation of the study portal and dashboard, as applicable. Maintenance of the study specific documentation including the TMF requirements. Participate/attend Sponsor meetings as required
• Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections. To assist in the response to internal audits and Corrective Action Plan Agreement (CAPA) resolutions, as applicable

• Writing documents: Data Management Plan, Data Validation Plan, IWRS deployment Plan, Data Import Plan, Final Data Management Report
• Create/review CRF template, Edit Check specification, manual checks, presentations, CRF Completion Guidelines and training materials
• Perform review: Protocol, annotated CRF, Data Transfer Plan and datasets, SAP, Statistical Report
• Verify the correct coding terms in MedDRA, WHO Drug and internal dictionaries
• Provide trainings to the projects team, investigators and a sponsor. Create presentations and present it at the investigator’s meetings and kick-off meetings
• Administer efficient data cleaning and supervise the activities of Data Management Assistant and Data Manager
• Perform/check SAE, IWRS/IVRS, laboratory data reconciliations
• Organize and take part in data review and database lock meetings
• Coordinate archiving, storing and updating of Data Management Documents
• Maintain project budgets and necessary additional agreements

• Managed projects;
• Developed Data Management Plan, Data Validation Plan;
• Created Edit Check specification;
• Administered system testing and validate test cases;
• Provided necessary trainings to entry staff, Data Management Assistant and clinical team;
• Managed Data Cleaning and Data Entry (including as a third referee for paper-based studies), Queries tracking and management;
• Checked coding adverse events and concomitant medications using coding dictionaries MedDRA, WHO Drug;
• Supervised the activities of Data Management Assistants.