Delia Georgescu

• Mentorship and Supervision: Mentor, coach, and supervise team members to ensure their professional development and performance.
• Team Management and Leadership: Manage a team of 5 individuals, ensuring effective coordination and performance.
• Resource Coordination: Coordinate resources across the entire Database Programming department (comprising 12 individuals): assign new projects, and allocate team members and hours per project.
• Project Forecasting: Perform monthly forecasting, estimating the required hours for each project/ per individual, for the next three months.
• CRF and Programming Input: Provide input and feedback in the design of aCRF, validation checks, and TPD programming.
• Study Build Oversight: Oversee study builds and support team members during Sponsor meetings.
• App Validation: Validate new applications for the Encapsia EDC system (Deploy, Dataviews and Loaders apps), by creating the User Requirement Specifications and Performance Qualification (PQ) tests.
• SME for Data Extractions: Serve as SME for data extractions, testing new processes from scratch, creating training guidance, and delivering departmental training for Database Programming, Data Management and SAS Programming.
• SME for Database Upgrades: Act as SME for database upgrades in Encapsia, testing various scenarios and documenting impact assessments for different types of changes.
• SOP Author and Reviewer: Develop the Data Extractions SOP from scratch and review and update the Database Build SOP to ensure it is system-agnostic.
• Process Improvement Leadership: Lead process improvement initiatives and facilitate cross-departmental meetings.
• Recruiting: Develop technical tests for candidate interviews, conduct CV screening, and participate in face-to-face or online interviews.

• Lead, supervise and implement procedures to build and maintain database set-ups in standard or CDISC compliant format
• Program validation checks according to Data Validation Specifications
• Provide feedback for study programmers on the creation of eCRF's following SOPs and internal process guidelines
• Lead Sponsor screen review meetings
• Provide technical support and mentoring junior members
• Maintain all supporting documentation for studies in accordance with SOPs to ensure traceability and regulatory compliance.

Create screens, visit schedules and database specifications , according to the study Protocol and Sponsor requirements

• Program validation checks according to Data Validation Specifications
• Integrate third-party data in EDC system , according to study requirements
• Lead Sponsor screen review meetings
• Create data extractions based on the aCRF
• Review database upgrade changes completed by team members prior to deployment to the Production environment.
• Subject matter expert on data extractions and database upgrades
• Develop libraries per Sponsor standards to allow efficient database programming
• Address database configuration tickets
• Represent department in meetings , discussions and activities pertaining to Database Programming
• Contribute to departmental processes and lead initiatives for improving the existing processes.

• Building and maintaining study frameworks in Cognos Framework Manager
• Programming clinical data reports in Report Studio
• Offering support and guidance to Data Management department
• Performing Cognos administrative activities (e.g. Live server troubleshooting )

• Screen and Schedule Creation : Design screens and visit schedules based on annotated CRFs and database specifications.
• Programming and Testing : Develop and test validation checks in Python according to Data Management Plan specifications.
• Data Loaders : Program routine third-party data loaders according to study requirements.
• Meetings: Lead Sponsor screen review meetings
• Specifications Input : Contribute to specifications for data structures, database applications, and validation checks to ensure they meet client or Cmed standards.
• Standards Adherence and Development : Follow Cmed and project standards and develop new standards for efficient database programming.
• Training and Mentoring : Train and mentor new joiners (screen development, validation checks and loaders programming)
• Process Contribution : Contribute to departmental procedures and take part in process improvement initiatives (e.g. libraries development).
• SOP : Follow standard operating procedures and ensure accurate documentation.

• Perform data validation and cleaning by generating and resolving queries
• Create study documentation , such as: Data Validation Specifications, User Acceptance Testing Package, Data Transfer Specifications
• Participate and Lead Sponsor meetings
• Train new employees (Training champion on "Handling Third Party Data" and "Status Reports")
• Create training guidance ("Handling TPD" and "Status Reports")
• Delegate tasks effectively to team members