Clinical Trials Research

Location:

Philadelphia, PA, 19146

Salary:

150000

Posted:

March 21, 2025

Contact this candidate

Resume:

Svyatoslav Milovanov

(Local to Philadelphia, PA)

CURRICULUM VITAE

NAME:

SVYATOSLAV MILOVANOV

LOCATION

***********@*****.***

M:+1-215-***-****

PRESENT POSITION:

GxP auditor Member of RQA, Consultant for consulting agencies on Medical Affairs, Freelance consultant for clinical trials stakeholders, Global Medical Monitor

ORCID, science skills

https://orcid.org/0000-0001-9843-6096

LINKED-IN

https://www.linkedin.com/in/svyatoslavmilovanov/

ResearchGate

https://www.researchgate.net/profile/Svyatoslav-Milovanov

US Tax regimen

W2 preferreabe

Detailed training received available upon request

SHORT BIOGRAPHY & MAIN EXPERIENCE

Svyatoslav Milovanov has more than 17 years of Phase I-IV clinical research and audit experience and manage trials in Oncology (solid tumors), Oncohaematology, Pulmonology, Cardiology, Dermatology, Immunology, Neurology, Ophthalmology, COVID-19.

Graduated in 2000 Dr. Svyatoslav Milovanov as a pediatrician he has been started his work in big regional hospital and worked on pediatric doctor positon during 7 years combining the job with university duties. Since 2008 fully dedicated to Clinical Trial industry on roles of Medical Monitor, CRA, Auditor, Study Physician for more than 15 years. 15+ years experience in clinical trials in oncology (hematology (lymphoma, ITP, HIT, etc), head and neck cancer, lung cancer, ovarian cancer, colorectal cancer and many others). Participated in sponsor’s and regulatory audits. Has international certificates and had internship in children nephrology in AKH in Vienna, also educated by CHOP Dr. Kevin Meyer. 2021 certified as an oncologist. Svyatoslav Milovanov experience regarding dealing with complex issues of submissions to regulatory authorities (FDA, EMEA etc), member of ACRES with founder of FDA - (Former FDA commissioner Greg Koski) customs issues, patient recruitment has always allowed to pass projects on time in accordance to plans. Participated in developing protocols (with RWD/RWE approach) for clinical trials since 2012 year for different clients by different nosology and phases

Summary:

GxP Audit for Oncohaematology, Pulmonology, Cardiology, Dermatology, Immunology, Neurology, Ophthalmology, COVID-19) Vaccine study, early phase of Diabetes & Respiratory study.

Responsible for the patient’s recruitment and engagement since 2006 year for over 15+ clinical trials in oncology, immunology, allergy

A Medical Monitoring/ Physician Study and Clinical Research professional with over 15+ years of experience.

Performed clinical trials with big pharma and small biotech sponsors. Covered over 100+ principal investigation sites on broad range of nosology in adult and pediatric oncology (solid tumors), Oncohaematology, Pulmonology, Cardiology, Dermatology, Immunology, Neurology, Ophthalmology, COVID-19) Vaccine study, early phase of Diabetes & Respiratory study.

Expertise includes Audit, Medical Writing & Documentation, Drug Safety & Pharmacovigilance, Clinical Operations & Site Management, Clinical Strategy Development per TA and FDA guideline, Clinical Trial Design and Clinical Research Ethics.

Acted as Clinical advisor for the entire lifecycle of the clinical trial by answering medical questions. AS well as during the recruitment eriod the Q\A sheet for I/E criteriem and other medical questions by investigators

Worked as Freelance consultant for clinical trials stakeholders, MRQA, Independent researcher.

Possess excellent communication, collaboration, and analytical skills.

Background in practicing medicine, clinical research, and familiarity with biostatistics, epidemiology and health outcomes preferred.

• Excellent English written and oral communication, interpersonal, and organization skills.

• High level of emotional intelligence.

• Demonstrated ability to work collaboratively in cross functional teams.

• Highest level of ethics and integrity.

Highlight of experience:

Strong self-management and self-development due to independently working for 2012 year till now.

Strong scientific and statistical skills.

Proficient in Electronic Data Capture Infosario, Medidata, RAVE, oracle, flex CTMS Pioneer and many more EDC, CTMS, Document saving and other platforms.

Familiarity with all phases of drug development.

Experience in leading complex projects and diverse, high-performance matrix teams.

Strong interpersonal skills to navigate complex situations and build alignment with key stakeholders.

Demonstrated ability to execute and deliver results in a deadline-driven environment.

Clear and effective verbal & written communication skills.

Areas of Expertise:

Therapeutic areas clinical trials with big pharma and small biotech sponsors. Covered over 100+ principal investigation sites on broad range of nosology in adult and pediatric (oncology (solid tumors), Oncohaematology, Pulmonology, Cardiology, Dermatology, Immunology, Neurology, Ophthalmology, COVID-19) Vaccine study, early phase of Diabetes & Respiratory study.

Phase I-IV Study

Data Analysis & Interpretation

Clinical Operations & Site Management

Clinical Strategy Development per TA and FDA guideline

Medical Writing & Documentation

Risk Assessment & Management

Team Building & Leadership

Regulatory Compliance

Stakeholder Engagement

Clinical Trial Design

Freelance consultant for

oGuidepoint

oDialectica

oTechspert

oClora

Clinical Research Ethics

Drug Safety & Pharmacovigilance

Science Profile:

ORCID, Science Skills: https://orcid.org/0000-0001-9843-6096

ResearchGate: https://www.researchgate.net/profile/Svyatoslav-Milovanov

Academia.edu: https://independent.academia.edu/SvyatoslavMilovanov

Auditor: https://dr-svyatoslavmilovanov-gcp-audit.tb.ru/

Inviting lecturer for North-Eastern Univerisity (USA)

Prediction of patient’s enrollment: https://predicting-of-clinical-trial-recruitment.tb.ru/predicting_of_recruitment_com

Editors for peer-reviewing scientific journals:

o“THE OPEN SPORTS SCIENCES JOURNAL”

oREVIEWS ON RECENT CLINICAL TRIALS

oAcademia Oncology (ISSN: 2998-7741)

oInternational Journal of Clinical Investigation and Case Reports

oClinical Interventions and Clinical Trials

oNeurons and Neurological Disorders

oBiomedical Review

oSciff.ru – Questions of student science

oJournal of Advances in Medical and Pharmaceutical Sciences

Skills:

Clinical & Medical Development Role:

oSince, 2007 year fully dedicated to the clinical trials on medical aspects of Phase I-IV clinical trials with big pharma and small biotech sponsors. Covered over 100+ principal investigation sites on broad range of nosology in adult and pediatric (oncology (solid tumors), Oncohematology, Pulmonology, Cardiology, Dermatology, Immunology, Neurology, Ophthalmology, COVID-19)

oPediatrician in big regional hospital for 7 years with knowledge of rehabilitology and sport medicine approaches. Sub investigator for pediatric studies.

Education:

Full professor (postdoc) degree in progress 2012 - 2025

Execuitive MBA (leadership) diploma in Nov 2024 ( health economics).

Oncologist, (diploma), 2021

AKH pediatric nephrology, Vienna, 2014

Diploma in Physics, Saratov State University, Saratov, 2004 – 2008

Ph D in medicine, Volgograd State Medical University, 2003

Sport medicine residency, Saratov State Medical University, 2000 – 2002

Pediatrics, Saratov State Medical University, Saratov, 1994 – 2000

Therapeutic areas:

General Pediatrician, oncologist, Pediatric nephrologist, Rehabilitologist.

Professional Training & Certifications:

2023 - RQA Member #00037515

2014 - ESMO member since 2014-year ID 314038

2022 - QARP certificate

2021 - Remote SDV

2021 – SIV training

2020 – Pharmacovigilance: the organization of work of holders of registration certificates with information on the safety of medicinal products.

2020- Regulatory requirements in Clinical Trial (certificate)

2020 – Pharmacovigilance (certificate)

2020, ICH GCP

2020, Updates of Regulatory requirements for Drug Clinical Trials

2020, Pharmacovigilance in Clinical Trials (Submissions to the RAs)

2020, Clinical trials during COVID 19 the pandemic, LLC

2019, Actual issues of the ethical examination of clinical trials, LLC

2019, Clinical trials of medical devices, LLC,

2019, Development of innovative pharmaceutical products in the field of pharmaceuticals and biotechnology, LLC

2019, Pharmacokinetics and Bioequivalence Studies: Good and Inappropriate Practice

2019, ICH GCP, LLC

2019, Project management and co-monitoring visit LLC

2018, AE Reporting and Source documents, LLC

2018, Audits and Inspections, LLC

2018, Clinical trials in obstetrics and gynecology General principles of the Good Clinical Practice (GCP), LLC

2018, ICH GCP, LLC

2018, Investigational product, LLC

Mar 2018 – certificate on E2 GCP

FEB-2018 - Infosario

30-APR-2015 - "Investigator-Initiated Studies – A Primer to Enhance Excellence and Compliance with FDA Regulations", СЕС

18-22 Apr 2015 – AACR training in Philadelphia PA on cancer research, FDA requirements etc.

24 – DEC 2014 – webinars

2014 – free GCP inspections course by Astra Nova

10-DEC-2014 webinars on FDA

01-NOV-2014 – 30-NOV-2014 – Observer ship in Vienna, Austria at AKH hospital on pediatric nephrology (certificate)

21-JAN2014 01 MAR 2014– volunteer on Sochi 2014 Olympic games

2014 – Webinar - Insights to Overcome Common GCP Challenges - From Consent to Documentation to Reporting – 29-OCT-2014. George Gasparis

2014 – Y-Prime EDC (certificate)

April 14, 2013 - FREE SESSION - An FDA Inspection of a Clinical Research Site: Part 1 remotely on ACRP 2013 Global Conference & Exhibition.

2013 – Edc Aptive solutions (certificate)

2012 – IWRS trainer (certificate)

2011 – RDC training on trainer

2008 (June) – IELTS

2007 – CRA GCP Training from KRC on-line (certificate) http://www.krctraining.com

Professional Experience:

Medical Monitor/ Study Physician/ Clinical Research Consultant Jun 2008 – Present

Clients: Aileron Pharm (USA), Synta Pharma (USA), Light Science Oncology (USA), K-beta pharma (USA), CEL-SCI pharma (USA), Constellation Pharma (USA), Aeterna-Zentalis (Germany), OCTAPHARMA (Switzerland), etc.

Responsibilities:

Clinical advisor for the entire lifecycle of the clinical trial by answering medical questions.

Participates actively in the project meetings by giving his/her medical advice.

Reviews study data listing from a medical point of view.

Analyzes and makes an independent interpretation of study data/results.

Writes and/or reviews protocol, Case Report Form (CRF) and Clinical Study Reports (CSR)

Provides training in specific disease/therapeutic area.

Providing high level consultancy support to Investigators and Sub-Investigators in clinical study execution

Assisting the SM and PM teams in identification of study site.

Providing study specific training to the members of the study team.

Assisting the study team in study preparation.

Development of protocol.

Development of protocol design for FDA EMEA, RA of other countries.