Senior Manager Of Clinical Operations
CurrentProject Management and Line Management. Staff selection and management, business development and clinical operations,
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Dmitriy Moskalenko is listed as Senior Manager of Clinical Operations at ICON plc, a with 10597 employees, based in Ukraine. AeroLeads shows a work email signal at mail.ru and a matched LinkedIn profile for Dmitriy Moskalenko.
Dmitriy Moskalenko previously worked as Senior Manager of Clinical Operations at Pra Health Sciences and Clinical Operations Manager at Pra International. Dmitriy Moskalenko holds Phd, Occupational Health from National Medical University 'O.O. Bogomolec', Kyiv.
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More than 10 years in clinical research area: participation in Clinical Trials in gynecology, psychiatry, surgery, neurology (Alzheimer's disease and vascular dementia), pediatric, oncology, therapeutic areasMD and PhD in medicineTrainee QA experienceCertified Trainer of ICH GCP E6Trainings: more than 50 trainings in Clinical Research area
Listed skills include Ich Gcp, Clinical Trials, Therapeutic Areas, Oncology, and 11 others.
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Kyiv City, Ukraine
Project Management and Line Management. Staff selection and management, business development and clinical operations,
Ukraine
Project Management and Line Management. Staff selection and management, business development and clinical operations,
Monitoring and local management of clinical trial according to ICH GCP and legal requirements
Ukraine
Feasibility conducting;Investigators/Institutions recruitment;Investigators/Institutions contracts/budget negotiation/preparation;Selective/Pre-study site visits conducting/reporting;Site Initiation visits conducting/reporting;Routine monitoring/Close-out site visits conducting/reporting;Investigators re-training on GCP/ICH guidelines;Investigators/Institutions study payments coordination;Study documentation update in accordance with the current local legislation… Show more Feasibility conducting;Investigators/Institutions recruitment;Investigators/Institutions contracts/budget negotiation/preparation;Selective/Pre-study site visits conducting/reporting;Site Initiation visits conducting/reporting;Routine monitoring/Close-out site visits conducting/reporting;Investigators re-training on GCP/ICH guidelines;Investigators/Institutions study payments coordination;Study documentation update in accordance with the current local legislation (ICF, Labels, Insurance, Patient items etc.);Complete CA/CEC interaction;Study Protocols/Amendments/Reports/Notifications submissions to CA/CEC;SUSARs management, dispatching to Investigators/CA/CEC;Local vendors interaction (customs, warehouses, translation agencies, travel agencies, couriers);Interaction with local Insurance companies regarding patients Insurance;SAEs management;Study Master File / Project File set-up and maintenance.Neurologic trial: multicenter randomized double-blind placebo-controlled study, phase II, 8 trial sites in Ukraine.Psychiatric trial: multicenter randomized double-blind placebo-controlled study, phase II, 8 trial sites in Ukraine, 4 trial sites in Moldova.Acute menopausal complaints: multicenter randomized double-blind placebo-controlled study, phase III (trial concept and protocol development). Show less
Ukraine
Line CRA's Management;Investigators/Institutions recruitment;Investigators/Institutions contracts/budget negotiation/preparation;Investigators/Institutions study payments coordination;Local vendors interaction (customs, warehouses, translation agencies, travel agencies, couriers);Study budget negotiation.
Kiev
May 2002 – Jan 2005Clinical Research Associate I-IIResponsibility: Monitoring and local management of clinical trial according to ICH GCP and legal requirementsProjects: Therapeutic trial: multicenter randomized double-blind placebo-controlled study in children, phase III, 8 trial sites in Ukraine (international audit was conducted) Psychiatric trial: multicenter randomized double-blind placebo-controlled study, phase III, 5 trial sites in Ukraine… Show more May 2002 – Jan 2005Clinical Research Associate I-IIResponsibility: Monitoring and local management of clinical trial according to ICH GCP and legal requirementsProjects: Therapeutic trial: multicenter randomized double-blind placebo-controlled study in children, phase III, 8 trial sites in Ukraine (international audit was conducted) Psychiatric trial: multicenter randomized double-blind placebo-controlled study, phase III, 5 trial sites in Ukraine (international audit was conducted) Therapeutic trial: multicenter randomized double-blind placebo-controlled study, phase III, 8 trial sites in Ukraine (international audit was conducted) Psychiatric trial: multicenter randomized double-blind placebo-controlled study, phase III, 7 trial sites in Ukraine (international audit was conducted)Jan 2005 – Aug 2007Clinical Research Associate IIIResponsibility: Monitoring of clinical trial according to ICH GCP and legal requirementsProjects: Psychiatric trial: multicenter randomized double-blind placebo-controlled study, phase III, 4 trial sites in Ukraine (international audit was conducted) Therapeutic trial: multicenter randomized double-blind placebo-controlled study, phase III, 6 trial sites in Ukraine (international audit was conducted) Show less
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Craig B.
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Quick answers generated from the profile data available on this page.
Dmitriy Moskalenko works for ICON plc.
Dmitriy Moskalenko is listed as Senior Manager of Clinical Operations at ICON plc.
AeroLeads has found 1 work email signal at @mail.ru for Dmitriy Moskalenko at ICON plc.
Dmitriy Moskalenko is based in Ukraine while working with ICON plc.
Dmitriy Moskalenko has worked for Icon Plc, Pra Health Sciences, Pra International, Alpen Pharma Ag, and Schwabe/Dhu/Ukraine.
Dmitriy Moskalenko's colleagues at ICON plc include Dallas Grubb, Stephanie Osorio, Angie Sofia Reyes, Deepthi Ram, and Andy Earl.
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Dmitriy Moskalenko holds Phd, Occupational Health from National Medical University 'O.O. Bogomolec', Kyiv.
Dmitriy Moskalenko is listed with skills including Ich Gcp, Clinical Trials, Therapeutic Areas, Oncology, Clinical Research, Protocol, Neurology, and Clinical Operations.
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