Mag. Silvia Benko

- Study Build (eCRF design, DVS specification, UAT) in alignment with protocol - DMP, eCCGs, protocol specific conventions creation - Project Plan creation and ensure the timelines are met - Query management - Database Lock - Participation in SIVs, Monitors training/meeting - Co-operation with external vendors - Cross-functional cooperation - Study data management - SOPs preparation

Acted as Clinical Data Manager for assigned studies in newly created team (cardiovascular, immunology, oncology therapeutic area, phases III-IV); participation in study build process (incl. designing eCRFs, UAT) and database locks; active participation in training sessions provided by Lead CDM; active participation in conference calls and providing timely, control team updates to higher management • SW used: Oracle Clinical, OC-RDC, Oracle Discoverer, JReview, Medidata RAVE, Inform

• Responsibilities included liaison with the sponsor as needed; mentored and trained associate safety data coordinators; trained and followed sponsor’s Standard Operating Procedures; issued and reviewed queries; tracked pending safety database updates; maintained and posted reconciliation spreadsheet; communicated safety status/progress/updated with the project team; performed final reconciliation before database lock • SW used: Oracle Clinical, OC-RDC, Oracle Discoverer, JReview, Argus Safety

• Responsibilities included liaison with the sponsor as needed; trained and followed sponsor’s Standard Operating Procedures; issued and reviewed queries; tracked pending safety database updates; maintained and posted reconciliation spreadsheet; provided input on safety status/progress/updated to the project lead; performed final reconciliation before database lock • SW used: Oracle Clinical, OC-RDC, Oracle Discoverer, JReview, Argus Safety

• Responsibilities included BT & IT Global CF Systems Run Legacy system support and T&C management; 1st level system support for ordering systems ; T&C management; Internal customers support