Olga Grytsenko Email and Phone Number

• Medical Review Planning and Execution: Lead the planning, organization, and execution of medical review activities, ensuring thorough and accurate evaluations.• Database Coordination: Oversee the medical review of clinical study databases, ensuring data integrity and compliance with medical standards.• Review Activities: Conduct detailed medical reviews, including assessments of listings, patient profiles, and CRF (Case Report Form) consistency, medical relevance, and… Show more • Medical Review Planning and Execution: Lead the planning, organization, and execution of medical review activities, ensuring thorough and accurate evaluations.• Database Coordination: Oversee the medical review of clinical study databases, ensuring data integrity and compliance with medical standards.• Review Activities: Conduct detailed medical reviews, including assessments of listings, patient profiles, and CRF (Case Report Form) consistency, medical relevance, and plausibility.• Documentation Development: Contribute to the creation of Medical Data Review Plans, Medical Review Checklists, Data Validation Plans and related documentation to guide review processes.• CRF and Data Collection Forms: Assess CRF designs for accuracy and compliance with study protocols. Participate in the development and evaluation of project-specific CRFs, data collection forms, and CRF completion guidelines to ensure alignment with study protocols.• Medical Coding Oversight: Review and coordinate medical coding processes in accordance with coding dictionaries to maintain data consistency.• Disputable Case Review: Address and resolve disputable cases identified during the reconciliation of clinical and safety databases.• Clinical Study Reports: Review clinical study reports and patient narratives, contributing to comprehensive and accurate documentation.• Collaboration: Engage with Data Management, Medical Monitors and Pharmacovigilance teams to ensure effective medical review of databases and reconcile clinical versus safety data.• Presentations and Training: Prepare and deliver presentations on medical review activities at corporate meetings and develop project-specific training for investigators and clinical teams. Show less

coordination of investigator/ site identification process; coordination of feasibility research; coordination of startup processes; review and approval of IP-RED/ site regulatory packages; facilitation of site budget and contract negotiations; management of investigator/site payments; monitoring of project timelines and patient enrollment, implementation of respective corrective and preventive measures; support of project team in preparation for study audits, resolution of audit… Show more coordination of investigator/ site identification process; coordination of feasibility research; coordination of startup processes; review and approval of IP-RED/ site regulatory packages; facilitation of site budget and contract negotiations; management of investigator/site payments; monitoring of project timelines and patient enrollment, implementation of respective corrective and preventive measures; support of project team in preparation for study audits, resolution of audit findings, and preparing audit responses on a country/regional level; facilitation and monitoring of the flow of documents/ reports and laboratory supplies; coordination and monitoring of clinical supplies management; review of monitoring visit reports for all visit types; leading project team calls on a country level; coordination and monitoring of an adequate safety information flow and protocol deviation reporting; preparation and delivery of presentations at Investigator meetings; maintenance of study-specific and corporate tracking systems at site and country level;ensuring proper handling, accountability, and reconciliation of all Investigational Product(s) and clinical study supplies; review of Risk Based Monitoring related information influencing data quality and frequency of site visits.Therapeutic areas: Neurology, Hematology, Oncology, Pulmonology, Intensive Care, Surgery Show less

acting as the main line of communication between the Sponsor and the site; preparation, conduct, and report of site selection, initiation, routine monitoring, and close-out visits; maintenance of study-specific and corporate tracking systems at site and country/regional level; performance of source data verification and follow up on data queries at site level; review of Risk Based Monitoring related information influencing data quality and frequency of site visits; ensuring proper handling… Show more acting as the main line of communication between the Sponsor and the site; preparation, conduct, and report of site selection, initiation, routine monitoring, and close-out visits; maintenance of study-specific and corporate tracking systems at site and country/regional level; performance of source data verification and follow up on data queries at site level; review of Risk Based Monitoring related information influencing data quality and frequency of site visits; ensuring proper handling, accountability, and reconciliation of all IP and clinical study supplies; review of the status and contents of essential documents and site level; support in preparation of draft regulatory and ethics committee submission packages; facilitation of site budget and contract negotiations; management of investigator site payments; project-specific training of investigators; support in preparation of investigator newsletters; ensuring ongoing evaluation of quality at a site and country/regional level; participation in study site audits and QC visits; support of project team in preparation for study audits, resolution of audit findings, and preparing audit responses on a country/regional level; support of project team in CAPA development and implementation; coordination of investigator/site identification process; coordination of startup processes; review and approval of IP-RED/site regulatory packages; monitoring of project timelines and patient enrollment, and implementation of respective corrective and preventive measures; review of monitoring visit reports for all visit types; support of monitors with query resolution process; conduct of study-specific co-monitoring visits; support of the monitor with budget and contract negotiation with the site; ensuring timely and correct invoicing and payment of sites/investigators; leading project team calls on a country level; coordination of feasibility research; Show less

maintenance of study-specific and corporate tracking systems at site level; ensuring ongoing evaluation of quality at site level; facilitation of site budgets and contract negotiations; acting as the main line of communication between the Sponsor and the site; building and maintenance of good rapport with the site staff involved in the conduct of the study; preparation, conduct, and report of site selection, initiation, routine monitoring, and close-out visits; patient enrollment monitoring;… Show more maintenance of study-specific and corporate tracking systems at site level; ensuring ongoing evaluation of quality at site level; facilitation of site budgets and contract negotiations; acting as the main line of communication between the Sponsor and the site; building and maintenance of good rapport with the site staff involved in the conduct of the study; preparation, conduct, and report of site selection, initiation, routine monitoring, and close-out visits; patient enrollment monitoring; ensuring accurate and timely reporting and follow up of AE/SAE and protocol deviations; performance of source data verification and follow up on data queries at site level; review of Risk Based Monitoring related information influencing data quality and frequency of site visits; ensuring proper handling, accountability, and reconciliation of all IP and clinical study supplies; review of the status and contents of essential documents; reconciliation of study OSF/TMF at site level; facilitation of the documents and laboratory supplies flow; support in preparation of draft regulatory and ethics committee submission packages; support in collection of IP-REDS packages at site/country level; project specific training of investigators; support in preparation of investigator newsletters; participation in study site audits and client onsite visits; ; facilitation of site budgets and contract negotiations; management of investigator site payments; site audit preparation visits and site audit findings resolution; field training of monitors; feasibility research; Show less

site selection, initiation, routine monitoring and close-out visits conduct and reporting; site management; project-specific training of investigators and site teams; management of communication between sponsor and sites; monitoring of patients’ enrollment at site level; ensuring S/AE and protocol deviations proper reporting and follow up; ensuring proper accountability and reconciliation of Investigational Product(s) and clinical supplies; review of essential documents and study OSF/PMF;… Show more site selection, initiation, routine monitoring and close-out visits conduct and reporting; site management; project-specific training of investigators and site teams; management of communication between sponsor and sites; monitoring of patients’ enrollment at site level; ensuring S/AE and protocol deviations proper reporting and follow up; ensuring proper accountability and reconciliation of Investigational Product(s) and clinical supplies; review of essential documents and study OSF/PMF; source data verification; support of IP-REDs packages preparation, as well as regulatory and ethics committee submission packages preparation; maintenance of study-specific and corporate tracking systems at site level; facilitation of documents, records, and laboratory supplies flow between trial sites and the Central/Regional Lab/Central Reviewer; ensuring ongoing evaluation of quality at site level; ensuring compliance with ICH GCP, regulatory and PSI/Sponsor specific requirements; Show less

- creation and development of client base; - developing and carrying out of presentations; - attracting customers of medical/pharmacy markets and promoting cooperation within mutual interests field; - development of the long-term productive relations with clients (physicians/pharmacists); - regular accounting of sales plan performance; - participation in tenders

- providing medical care for patients; - educating patients as for diseases prevention and health maintenance; - preparing medical records, clinical reports; supervising nurses, physician assistants and medical assistants