Olena Romanova

• Resourcing and Line manager • aPDM role in projects from March 2018 • Communication with sponsor, vendors and internal teams; participation in sponsor meetings • Support of Lead Project Data Manager and involvement in all data management processes in studies • Preparation of specification

• Project leader for all data management aspects. • Serve as the project and client liaison. • Development of Data Management Plans, Trial Design, PD document, ets. • Interaction and collaboration with other project teams (client, clinical, programming, statistics). • Development of specification for programming of medical review listings, protocol deviations, patient profiles; coordination of programming. • Budget, forecast and revenue recognition

• Resourcing and Line manager • aPDM role in number of projects from March 2018 • Communication with sponsor, clinical operations and internal teams (programming and data management) in projects • Responsible for all data processing tasks and deliverables on assigned projects

• PDM support • Resourcing manager • UAT of edit checks, Screen UAT, Role Test • Functional QC activities and testing • Create CRF Completion Guidelines (eCCG) • Routine data review and cleaning • SAE reconciliation • Metrics reports preparation

• Efficient and effective execution of Phase III clinical trials; • Clinical Site Monitoring (Selection, Initiation, Interim Monitoring).

• Contract negotiation and execution; • Customization of Informed Consent Forms (ICF); • Country-specific feasibility; • Collection of Site Regulatory Packages (SRP); • Preparation and submission of RA/EC applications

• Efficient and effective execution of Phase III clinical trials; • Clinical Site Monitoring (Selection, Initiation, Interim Monitoring).

Bioinformatics, Tumor Biology, Experimental Design, Experimental biomedicine

Pharmacology, Physiology, Anatomy, Pathology, Biochemistry, Clinical Pharmacology, Pharmaceutical Chemistry