Olena Romanova
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Olena Romanova
- Bis heute 6 Jahre und 9 Monate, seit Nov. 2018
Associate Project Data Manager
Covance FSPx
• 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
- 6 Monate, Sep. 2019 - Feb. 2020
Clinical Data Manager
Covance
• 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
- 5 Monate, Juli 2018 - Nov. 2018
Clinical Data Analyst II
Covance FSPx (previously Chiltern)
• 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
- 1 Jahr und 7 Monate, Jan. 2017 - Juli 2018
Clinical Data Analyst I
Chiltern
• 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
- 1 Jahr und 11 Monate, März 2015 - Jan. 2017
Clinical Research Associate II
InventiveHealth
• Efficient and effective execution of Phase III clinical trials; • Clinical Site Monitoring (Selection, Initiation, Interim Monitoring).
- 1 Jahr und 9 Monate, Juli 2013 - März 2015
Clinical Trial Specialist
PARAXEL
• 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
- 1 Jahr und 8 Monate, Jan. 2011 - Aug. 2012
Clinical Research Associate
IQVIA - Quintiles and IMS Health are now IQVIA
• Efficient and effective execution of Phase III clinical trials; • Clinical Site Monitoring (Selection, Initiation, Interim Monitoring).
Ausbildung von Olena Romanova
- 11 Monate, Aug. 2012 - Juni 2013
Biomedicine
University of Skovde (Sweden)
Bioinformatics, Tumor Biology, Experimental Design, Experimental biomedicine
- 4 Jahre und 10 Monate, Sep. 2005 - Juni 2010
Pharmacy
National University of Pharmacy (Ukraine)
Pharmacology, Physiology, Anatomy, Pathology, Biochemistry, Clinical Pharmacology, Pharmaceutical Chemistry
Sprachen
Englisch
Fließend
Deutsch
Gut
Russisch
Muttersprache
Ukrainian
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