Олександр

Name Oleksandr Kosarenko
Date of birth 1983/01/08
Nationality Ukrainian
Tel. mobile [відкрити контакти](див. вище в блоці «контактна інформація»)
E-mail [відкрити контакти](див. вище в блоці «контактна інформація»)

Objective position/job Contractor, Clinical research and Pharmacovigilance

Education 2000-2006 Kyiv National Medical University
Second Medical Department
MD

Work Experience Nov 2018 – till now Contract services, Clinical Research

• Regulatory consultancy
• Regulatory submissions
• Monitoring
• Local Project Management
AML, HIV, Lung Cancer (Phase 3)

Jun 2017 – Oct 2018 BIORASI LLC representative office in Ukraine
Local Project Manager/Senior CRA (till Oct 2017)

• Start-up activities supervision
• Communication with RA top executives (protocols, remarks, issues)
• Contracts review and negotiation (sponsor, sites, vendors)
• Identify and evaluate fundamental issues
• Recruitment strategy development and execution
• Project management plans development
• Budgeting on Country level
• Line management of CRAs
• Staff recruitment, mentoring and training
• Support BD department in bid defense meetings
• Culture and automatization development
• Local Management of unique high caliber stem cell study,
Neurosurgery (Traumatic Brain Injury) (Phase II)

Jun 2016 – May 2017 BIOPHARMA LLC (STADA Group)
Head of clinical research department

• Management of clinical studies from startup to closeout
• Accountability for ensuring all project deliverables
• Identify and evaluate fundamental issues on the project
• Communication with RA (studies approval, marketing auth. req.)
• Direction of the technical, protocol-specific and operational aspects
• Collaboration with major functional areas within company
• Selection of new & supervision of existing contractors (UA, BY, GE)
• Line management of CRAs
• Experience in Orphan blood disease studies (PID, Hemophilia A)

Mar 2011 – Oct 2015 Alpen Pharma AG
Representative office in Ukraine
Senior CRA /Local Project Manager (since Dec 2012)

• RA & EC submission, approval obtaining, issues communication
• Pre-study, Initiation, Monitoring, Close-out and Co-monitoring visits
• MVRs preparation/review
• Weekly Country Status Report preparation
• Study specific trainings for CRAs
• Local project management (clinical and administrative)
• Country Study budget compliance, Invoices for Sponsor preparation
• Investigator/Institution contracts development and review
• Investigator & Institution payments tracking
• IP custom clearance and destruction organization

Neurology (phase III) (Senior CRA)
Neurology (phase III) (Senior CRA)
Neurology (phase III) (Senior CRA)
ENT (phase III) (LPM for Ukraine)

Feb 2010 – Feb 2011 Monipol GmbH
Clinical Research Associate (contractor)

• Pre-study, Initiation, Monitoring, Close-out visits
• Study vendors selection and management
• Study specific training for study Nurses
• Payments to Investigators & Institutions tracking

Oncology (phase I) (Bioequivalence study)
Oncology (phase I) (Bioequivalence study)

Aug 2008 – Aug 2009 AstraZeneca UK Limited
Representative office in Ukraine
Clinical Research Associate

• Feasibility preparation
• Regulatory submission preparation
• Pre-study, Initiation, Monitoring, Close-out visits

Endocrinology (phase II) (Local Study Delivery Team Leader)
Endocrinology (phase III) (Monitor)
Cardiology (phase III) (Monitor)

July 2007 - Dec 2007 Innopharm-Ukraine ltd., CRO (PPD)
Clinical Research Associate

• Pre-study, Initiation, Monitoring, Close-out visits

Endocrinology (phase II) (Monitor)
Endocrinology (phase III) (Monitor)

Dec 2006 - June 2007 Innopharm-Ukraine ltd., CRO (PPD)
Clinical Research Associate Assistant

Trainings Oct 2016 Bioavailability and Bioequivalence studies,
Updated EMA requirements and National RA

Oct 2012 4th Scientific and Practical conference
“Clinical trials of medicinal products in Ukraine”
State Expert Center of Ministry of Health of Ukraine

Feb 2010 Training on Phase I studies,
Monipol phase I unit, Krakow, Poland

Oct 2008 2nd Scientific and Practical conference
“Clinical trials of medicinal products in Ukraine”
State Expert Center of Ministry of Health of Ukraine
Sep 2008 Regional Procedural Training,
AstraZeneca, Warsaw, Poland
Aug 2007 Training on Siebel CTMS,
PPD, Cambridge, UK

Dec 2006 Training on Monitoring of Clinical Trials according to
ICH-GCP, Innopharm - Ukraine, Kyiv
Dec 2006 Introductory Training on Clinical Trials and ICH-GCP,
Innopharm - Ukraine, Kyiv

Language proficiency Ukrainian – native, English, Russian – fluent

References Available upon request