Резюме від 15 січня 2024 Файл

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Фахівець з клінічних досліджень

Вік:
44 роки
Місто:
Київ

Контактна інформація

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Curriculum Vitae
Igor Rudenko, MD, PMP

Phone: [відкрити контакти](див. вище в блоці «контактна інформація»)

E-mail:[відкрити контакти](див. вище в блоці «контактна інформація»)

Education

Bogomolets National Medical University, Kyiv, Ukraine (1997-2003)
Medical Degree

Shupyk National Medical Academy of
Postgraduate Education, Kyiv, Ukraine (2003-2004)
Board Certification Dermatologist

Bogomolets National Medical University, Kyiv, Ukraine (2004-2006)
Dermatology Fellowship

Project Management Institute, Philadelphia, USA (2012)
Project Management Professional Grade

USMLE Step1 (2014)

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Summary

• 7,5 years of experience working in clinical research (including 1,5 years in Medical monitoring, 4 years of clinical project management, 2 years of monitoring)
• 20 years clinical experience in aesthetic dermatology (including part-time activities)
• 17 years clinical experience in dermatology (including part-time activities)
• 13 year in training activities (10 of them – on the level of International Faculty)

• Therapeutic Areas:
◦ Dermatology and Aesthetic Medicine
◦ Oncology
◦ Neurology
◦ Cardiology
◦ Respiratory Diseases

Professional Experience

Aesthetic Consilium Group (Ukraine)
Medical Director
Apr 2015 – Feb 2022

1) Aesthetic Consilium Clinic – Aesthetic Clinic, 500 Sq m, 40 employees, 10 physicians
2) Aesthetic Consilium School - training center for physicians in Aesthetic Medicine (Started on Nov 2015) – more than 100 trainings were done
3) Aesthetic Consilium Conferences - events dedicated to Aesthetic Medicine (Grand Experts Meeting in Kiev –12 event done since Jan 2015, Kolkhida in Tbilisi – 4 events since July 2015, Aesthetic Consilium Congress “Christmas Prague” – Dec 2016 and Dec 2018 (Last conference had 500 participants, in the 2018 the biggest Aesthetic Conference in Czech Republic)
4) Aesthetic Consilium Science- Developing system, that supports aesthetic physicians in case of complication and successfully implemented on the platform of IMCAS Academy under the commercial name IMCAS Alert (Now Headliner for IMCAS and the biggest world anti - complication system in Aesthetic)

Ganymed/BioNtech Pharmaceuticals (Germany)
Clinical Research Physician (0,8 FTE)
Clinical Project Manager(CRO compliance – 0,2 FTE)
Jul 2014 –March 2015)

(Monoclonal antibody, gastric cancer, phase II)

Medical monitoring and review of medical data from clinical trials
SAE review
Patient cases preparation for publication and due diligence process
Protocol Deviations review and evaluation
Manage and support the oncology clinical studies (Phase I-II, Europe)
Development and maintenance of a tracking/reporting system/tool for study site management
Overseeing CRO / CRA performance at study sites and regular progress reporting to study teams
Contribution and review of clinical key documents such as study protocol, investigator brochure, informed consent form, etc. in close collaboration with study team leader and relevant functions, e.g. Preclinical, Regulatory Affairs, Pharmacovigilance, Preparation of regulatory authority and Ethics submission
Contributions in the development of Standard Operating Procedures (SOPs)

ICON Clinical Research (Germany)
Senior Clinical Research Physician
Oct 2013 to Jun 2014
(Monoclonal antibody, Atopic Dermatitis, Phase II,
Botulinum toxin, spastic paralysis, Phase III)

Medical monitoring and review of medical data
Support study team within frameworks of medical issues in clinical trials
Protocol review and design
Medical training for ICON staff and investigators
Provision of medical/scientific, especially dermatological, consultation and therapeutic expertise for clients and ICON staff
Business development support
Discussion of study specific dermatological topics with principal investigators

GlaxoSmithKline (Ukraine)
Clinical Project Manager
Jun 2008 to Jun 2012
(Breast cancer, phase III
Chronic Heart Diseases, Phase III
COPD, phases II-III
Bronchial Asthma, phase II
Allergic Rhinitis, Phase II)

Study management, incl. oncology, respiratory, and cardiology studies
Clinical management of ~ 10 trials, phase II-III, with budget, time, staff, communication, quality and risk planning
Management of CRO CRAs, site selection, ethics committee and regulatory authorities (study submission), vendor selection

ClinStar Ukraine
SCRA
Jun 2006 to Jun 2008
(Atrial Fibrillation – phase III
Hip and Knee replacement – Phase III
Melanoma – Phase III)

Conduct of feasibility studies including sites and principal investigator selection, managing site-related activities, insurance of quality and integrity of data in accordance with ICH GCP, applicable regulations, and sponsor SOPs
Conduct of unblinded and drug-control monitoring with IP accountability and return

Clinical Activities (Training and Practice in Ukraine)

CALM Clinic
Dermatologist
Apr 2023 - Current

Dermatological and Aesthetic Medicine clinical practice
(skin surgery, stem cells transplantation, lipofilling and liporeduction, botulinum toxin, HA and CaHA fillers, PRP, thread lifting, Laser treatment, Body - countoring treatment, HIFU, radio-frequency and IPL-treatment. Treatment of complications in Aesthetic Medicine.
Diagnosis and treatment of dermatological diseases using dermatoscopy, US and radiosurgical methods. Established conduct of skin biopsies. Screening for malignant skin growth and deletion of benign formations. Treatment of malignant skin formations in collaboration with oncologists.

Aesthetic Consilium Clinic
Dermatologist
Sep 2015 – Feb 2022
Part –time position

Provision of wide range of anti-aging skin treatments including skin surgery, lipofilling, botulinum toxin, HA and CaHA fillers, TCA and Phenol peels, PRP, thread lifting, Laser treatment, Body - countoring treatment, HIFU, radio-frequency and IPL-treatment.
Diagnosis and treatment of dermatological diseases using dermatoscopy and radiosurgical methods. Established conduct of skin biopsies. Screening for malignant skin growth and deletion of benign formations. Treatment of malignant skin formations in collaboration with oncologists

Clinic of Healthy Aesthetology
Dermatologist
Nov 2011 to Jun2012
(part time clinical position)
Jul 2012 – Oct 2013
(Full time position)
Apr – 2015 – Sep 2015
Part time position

Provision of wide range of anti-aging skin treatments including botulinum toxin, HA and CaHA fillers, TCA peels, PRP, thread lifting, Laser treatment, Body - countoring treatment, radio-frequency and IPL-treatment
Diagnosis and treatment of dermatological diseases using dermatoscopy and radiosurgical methods. Established conduct of skin biopsies. Screening for malignant skin growth and deletion of benign formations. Treatment of malignant skin formations in collaboration with oncologists

Clinic of Family Medicine “Healthy Family”
Dermatologist (Practice)
Jul 2004 to Oct 2011
(part time clinical position)

Responsible for diagnosis and treatment of dermatological diseases. Administration of botulinum toxin and filler injections, conducting TCA peelings, PRP, thread lift, liposuction, mesotherapy, and laser treatment

National Medical University, Dermatology Department
Dermatology Fellowship
Jun 2004 to Jun 2006
(full time clinical position)

Diagnosis and treatment of dermatological diseases, conduct of research projects and lectures at dermatology congresses

Shupyk National Medical Academy of Postgraduate Education, Dermatology Department
Resident
Jun 2003 to Jun 2004
(full time clinical position)

Diagnosis and treatment of dermatological diseases

Selena Beauty Club Clinic
Aesthetic Dermatology Practitioner
Aug 2001 to Jul 2004
(part-time clinical position)

Administering botulinum toxin and fillers injections, mesotherapy, peels, and aesthetic dermatology consultations

Other Professional Activities

Independent Medical Expert, as
National Speaker and Certified International Expert
Sep 2009 to Sep 2013,
April 2015 - present
(Independent Contractor, Ukraine)

Contributor and lecturer at professional conferences, participation in expert forums
Author of the book: “Aesthetic Medicine. Complications after minimal invasive treatments. Protocols of correction” (2021)

Project Experience / Expertise

Cancer of the stomach
Melanoma
Benign skin growth
Psoriasis
Atopic dermatitis,
Eczema,
Acne,
Hair loss,
Pemphigus Vulgaris,
Vasculitis,
Rosacea,
Bacterial, Fungal and Viral skin infections
HA Fillers and Botulin toxin injections
Bronchial asthma
COPD
Atrial fibrillation
Ischemic heart disease
Breast cancer
Hip and knee joint replacement
Protocol review
Protocol writing
Patient cases preparation
Report review
Report writing
Study proposal writing
Study budget writing
Business contingency plan writing
Quality control
Regulatory reporting / Medical Affairs
Medical monitoring (site interaction)
Organization of Investigator Meetings
Clinical Project Management
Site selection
Site monitoring
Team training

Professional affiliation
IMCAS – Scientific Committee (injectables), IMCAS Alert coordinator (from 2017)
European Academy of Dermatology and Venereology membership (from 2014)
ACCME- accreditation for course for physicians of toxins and fillers usage (from 2013)
Member of Scientific committee IMCAS (Paris) (from 2014)

• Languages: Ukrainian (first language), English (fluent), Russian (fluent), German (beginner)
• Computer skills include: MS Office

References provided upon request

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