Clinical Data Management Specialist / Специалист по управлению данными( АстраЗенека )

Описание

Natalia Lytkina _ Sr CRA_ 11 Jan 2023 Page 1 of 4

Natalia Lytkina, MD, Senior CRA
ICON Clinical Research
Saint -Petersburg, Russia




Education

High School, Advanced courses in Cardiology, Nov 2004
State Medial University n.a. I.P.Pavlov, Saint-Petersburg, RU SSIA
High School, Advanced courses in Fun ctional Diagnostic, Oc t 2003
State Medial University n.a. I.P.Pavlov, Saint-Petersburg, RU SSIA
High School, Cli nical Residency in Therapeutics, Jun 2003
State U niversity, Medical Departme nt, Saint-Petersburg, RU SS IA
Fun ctional Services: Internal Medic ine , Gastroenterology, Hema tology,
Infectious Dis eases, Respiratory, Cardiology , Nephrology .
Gr adua te, Internship in Family Medicine, Jul 2001 Medical Academ y of Postgraduate E ducation, Saint-Petersburg, RU SS IA
Fun ctional Services: Cardio-Metabolic D iseases; Gastroenterology; Genitourinary, Infectious Dis eases; Neurology; Radiology; Respiratory
Gr adua te, Qualifi cation MD, Jun 1999 Pavlov State Medical Universit y, Saint-Petersburg, RU SS IA




Summary


• 16 years of experience in industry-spon sored clinical trials, participation in 15 + internation al stud ies in variou s
therapeutic areas(hema tology, imm uno logy, infection decea ses, neurology, on cology , hepatology, neph rology,
derma tology , gastroenterology ); in-depth kno wledg e of impleme ntation and condu ct of clinical studies (most of these
studies w ere performe d from f easibility phase, selection of sites, initiation , routine mon itoring to time ly study closure);
effective ti me-ma nageme nt and monitoring skills; good planning, organization and problem s olving abiliti es; result-
oriented approach ; excellent comm unication skills; nego tiation skills.

• Clinical Research Therapeutic Areas include:
Indication Phase I, II,
III, or IV
Highest Role Within
Indication
Thrombocytopenia (Hematology ) III Sr CRA
Rheumatoid Arthritis( Autoimmune disorders ) III Sr CRA
Surgical Anesthesia II Sr CRA
Hepatocellular Carcinoma (Oncology ) II Sr CRA
Urticaria (Dermatology ) III Sr CRA
Anemia (Hematology ) III Sr CRA
Cirrhosis (Hepatology ) II Sr CRA
Crohn's Disease (Gastroenterol ogy ) II,III Sr CRA

Natalia Lytkina_ Sr CRA _ 1 0 Mar 2023 Page 2 of 4
Psoriasis( Dermatology ) III Sr CRA
Ski n\Soft Tissue Infections (Antibacterial treatment ) II,III CRA
Intra -Abdominal Infections( Antibacterial treatment ) II,III CRA
Pediatric Urinary tract infections (Antibacterial treatment ) II Sr CRA
Hepatitis B in children( Antivirals ) III Sr CRA
Community Acquired pneumonia (Antibacterial treatment ) II CRA
Hospital Acquired pneumonia(Antibacterial treatment) II CRA
Multiple Sclerosis( Neurodegenerative Diseases ) III Sr CRA
NAS H( Nonalcoholic steatohe patitis ) III Sr CRA

• Professional Licenses/Affiliations/Memberships :
Project Management Professional (PMP) : Project Management Institute (PMI), GERMANY Acquired Date: Mar 2013
Expiration Date:N \A
• Expe rience in Electronic Data Capture trials :
Type System Name
Cli nical Tri al Manageme nt System s Siebel Clinical (CT MS ), ICOT rail
IVR S/IWRS/RT SM ERT, Yprime, Almac Clinical Services, Signant Health , Medidata
TMF Docume ntum E TMF, Phlex TMF , Veeva
• Languages (fluency, verbal and written) :
Language

Conversational

Re ading

Wri ting Medic al Rec ords
/Terminolog y
English High High High High
French High High High High
Japanese Low Low Low Low
Russian High High High High
• Geographic experience :
Country or Region Therapeutic Area Role
LATVIA Infecti ous Diseases Clinical Research Associate

LITHUANIA
Infectious Diseases Clinical Research Associate
POLAND Infectious Diseases Clinical Research Associate
RUSSIA Immunology, Dermatology, Infectious Diseases,
Hepatology, Neurology, Anesthesiology,
Hematology
Clinical Research Associate
UKRAINE Infectious Diseases Clinical Research Associate
EASTERN EUROPE,
WESTERN EUROPE
Oncology Clinical Researc h Associate
• Vendor experience :
Type Name
Central ECG & BP Mo nitoring eResearch Techno logy
Central Ima ging Services Robarts, Bioclinica, Bio-Ima ging Techno logies
Central Lab Services AC M, Q2, Covance, Eurorfins Medinet (Focus B io-Inova), ICON
Cli nical Data Manageme nt Signant Health, Yprime
healDr ug Developme nt Services Alma c Cli nical Services, Fisher
Drug Packaging & Distri bution Alma c Cli nical Services, Fisher
Import Licenses Alma c Cli nical Services
IXRS ERT, Yprime , Alma c Cli nical Services, Signant Health
Logisitics & Tr ansportation DHL ,TNT, World courier.

Natalia Lytkina_ Sr CRA _ 1 0 Mar 2023 Page 3 of 4
Professional Experience


ICON Clinical Research
Job Title

Senior CRA, Clinical Operations
ICON, forme rly PRA H ealth Sciences, Saint-Petersburg, Leningrad region, RU SSIA
Apr 2014 - Present (9yrs)


Study Assi gnments





Role :
Sr CRA
Period(s):
Apr 20 14 -
Cu rrent
Accomplishments:
Timely visits performance, reporting, sites' management.
Responsibilities :
• Implements and monitors cl inical trials to ensure sponsor and investigator
obligations are being met and a re compliant with applicable local regulatory
requirements and ICH -GCP guidelines
• Assesses the qualification of potential investigative sites, initiates clinical
trials at in vestigative sites,
instructs site personnel on the proper conduct of clinical tr ials, and close
clinical trials at investigative sites
• Reviews and verifies accuracy of clinical trial data collected, either onsite or
remotely
• Provides regular site statu s information to team members, trial
management, and updates trial management to ols
• Completes monitoring activity documents as required by PRA SOPs or
other contractual obligations
• Works closely with other clinical team members to facilitate timely res olution
of trial and/or clinical issues
• Escalates site and trial related issue s per PRA SOPs, until identified issues
are resolved or closed
• Performs essential document site file reconciliation
• Performs source document verification and query resolution
• Assesses IP accountability, dispensation, and compliance at the
investigati ve sites
• Verifies Serious Adverse Event (SAE) reporting according to trial
specifications and ICH -GCP
guidelines
• C ommunicates with investigative sites
• Updates applicable tracking systems
• Ensures all required training is completed and documented
• S erves as observation visit leader
• Facilitates audit s and audit resolution
• Mentors junior level CRAs and serves as a resource for new employees
• Serves as observation and performance visit leader
• Functions independently with minimal oversight requir ed
• May be assigned to complex studies and/or sites

Natalia Lytkina_ Sr CRA _ 1 0 Mar 2023 Page 4 of 4
Previous Company Name : PS I CRO , Saint-Petersburg, RU SS IA
Job Titl e: Sr CRA

Aug 2007 -Apr 2014
(6yrs. 7mos )

Accomplishments:
Participation in sponsors' audits with no m ajor findings. Effective site
management, good communication with sites .
Responsibilities:
QA and QC of trials and coordination of independent audits
Participated in 2 FDA inspections
Made a review and approval of important stu dy related documents
Performed general and project -specific training of new staff
Planned and executed clinical studies in differe nt regions
Sites selection, initiation, monitoring and closure
Coordinated feasibility performance



Previo us Company Name : PS I CRO , Saint-Petersburg, RU SS IA
Job Title : CRA

Jul 200 5- Aug 20 07 (2yrs .)

Responsibilities :
Conducted fea sibility assessments of planned clinical studies Performed
sites' evaluation, initiation , monitoring and close -out visits Site management;
supplies management



Previous Company Name : City Clinical Hospital #26, Saint -Petersburg, RUSSIA
Job Title : MD
Sept 2003 - Jul 2005 (1yr,
7 mos )

Responsibilities :
Worked as therapeutist of re ception department of the hospital .