Специалист по клиническим исследованиям

Описание

1
Date: 10 -Jan -20 24


NAME EDUARD UMANETS, MD
POSITION Proposal Manager
DEPARTMENT Site Activation and Clinical Monitoring Pre -Award Strategy . Pre -Award
Planning and Pricing
EMPLOYMENT STATUS Syneo s Health Rus LLC employee
BUSINESS ADDRESS Letnikovskaya Street 2, Building 1 Business Center Vivaldi Plaza, Floor 10
Moscow, Russia . Home based. Saint Petersburg. Russia
BUSINESS CONTACTS Phone: +7 981 722 20 28 / E-mail : edward .umanets@gmail.com
LANGUAGES Russian (native), English (advanced), Polish
(intermediate)

EDUCATION

2021 Clinical Research Auditing Certification Program . Certificate of
Completion. Barnett Web Seminar . Division of Cambridge Innovation
Institute . 250 First Avenue, Suite 300 , Needham, MA 02494 , USA

2007 Doctor -Specialist in Ultrasound Diagnostic. (Certificate # 31134)
National Medical University; Faculty of Post -Diploma Education , Lvov,
Ukra ine

200 5 Obstetrics , Gynecology and General Ultrasound course . Certificate of
completion. City University of London , UK
2003 IELTS Academic Level , (Certificate # 03100114UMAE850A) Southwark
College, London, UK,

2002 Doctor - Specialist in General Medicine -Practice -Family Medicine.
(Certificate# 542)
Medical Academy of Post Diploma Education named after P.L. Shupik a,
Kiev, Ukrai ne

2000 Physician, General practice (Diploma ВН № 12173822)
Vinnitsa State Medical University named after Pirogov; Vinnitsa, Ukraine

PROFESSIONAL EXPERIENCE

Dec 20 22 – prese nt Syneos Health Clinical Solutions Proposal Manager

Develops moderately complex domestic and global proposal budget and
text documents.
Collaborates with team members, operations and business development,
to develop proposal submissions, including participation in internal
meetings as required .
Receives and analyzes Requests for Proposals (RFPs) from Business
Development (BD) and ensures appropriate Subject Matter Experts
(SMEs) are assigned to and notified of the RFP.
Prepares and modifies budgets for S tudy Star t-Up part, Central
Monitoring tools, and proposal text, responding to requests for proposals
(RFPs) and rebids based on feedback received from SMEs.

2
Ensures proposal text and budgets are in agreement with RFP, client
specifications and communications, and internal assumptions.
Obtains third party quotes as needed.
Manages the proposals process from RFP receipt to proposal delivery,
identifying potential barriers or risks for completion and identifying and
implementing mitigation strategies. Escalates to management when
deliverables are at risk based on process stag e gates.
Works with contracts, finance, and operations to facilitate project
initiation as part of Plan Activatio n.
Updates proposals and/or sales management tools, systems and/or forms
regarding proposal or rebid status and value as directed.
Coordinates and participates in project hand -over meetings.
Present budgets in client -specific/requested formats.
Provides functional guidance and application of process guidelines to
internal constituents as needed.
May perform peer QC prior to manager sign -off according to
departmental procedures and guidelines.
Suggests and implements pricing and proposal strategies to improve
quality of proposal. Collaborates with team members, operations, and
business development, to customize and develop proposal submissions.


Dec 20 20 – Nov 2022 Site Excellence Partner GSSO / Pfizer, M oscow, Russia
Site Excellence Partner - responsibilities are to ensure quality study conduct
at the investigator sites with a focus on risk mitigation, data integrity, patient
safety and regulatory compliance. Oversight of the monitoring vendors
remains a core component of the role. As part of the oversight
responsibilities, this role utilizes and interprets data from analytic tools, in
conjunction with country and regional intelligence to proactively identify
risks to quality and compliance and to develop and implement mitigation
pla ns to address these risks. This role is also accountable for identifying
CRA performance issues and is responsible for ensuring appropriate
corrective and preventative actions are put in place.




Sep 20 19 – Nov 2020 Site Relationship Partner GSSO / Pfizer, Moscow, Russia
The Site Relationship Partner is the main Pfizer point of contact for
investigative sites; accountable for site start -up activities through activation;
accountable for building and retaining investigator site relationships and
providing.
support from site recommendation through the lifecycle of studies.
The Site Relationship Partner proactively collaborates with key stakeholders
and provides local intelligence to country outreach surveys, investigators
strategies, and Pfizer pipeline opportunities. Additionally, the Site
Relationship
Partner will help coordinate with other roles and functions that will interface
with study sites, thereby, simplifying.
communications and enhancing overall visibility into and confidence of
quality of site -level activities.

3
Dec 2016 – Aug 2019 Regional Clinical Site Lead GCTE / Pfizer, Moscow, Russia
As a Regional Clinical Site Lead is responsible for in country site management
and clinical/medical/scientific oversight activities of assigned clinical trials to
ensure patient safety and quality study execution in accordance with applicable
prevailing laws, Good Clinical Practices, and Pfizer standards. Regional
Clinical Site Lead role is accountable for managing investigator site
relationships to ensure effective delivery of clinical trials (e.g. study start up,
enrollment, database release), to safeguard the quality of investigator sites
(e.g. site health, patient safety) and to maintain investigator and study coordinator
engagement and satisfaction.
The Regional Clinical Site Lead is the local expert for the assigned clinical trials
and brings that expertise to support the investigator site, which includes the
investigator, study coordinator, pharmacist etc, and to oversee and support the
site monitor in the conduct of clinical trials. This role is responsible for the
resolution of protocol -related issues at the local level.

Feb -2016 –Dec -2016 Compliance Oversight Lead, GCTE / Pfizer, Moscow, Russia
Acted as local oversight of assigned clinical trials to ensure patient safety and
quality study execution in accordance with prevailing laws, Good Clinical
Practices, and Pfizer standards (if applicable).
Was responsible for oversight of site and monitoring study execution for
assigned studies. Ensured overall quality and regulatory and GCP complian ce.
Conducted and reported oversight activities, both remote and onsite visits
according to Pfizer standards
Proactively identified, managed and escalated site issues and acted as Site
interface.
Ensured resolution of site issues in order to maintain sound investigator
relations. Maintained a thorough knowledge of protocol. Demonstrated TA
expertise where appropriate.
2008 -2015 CRA (CRAII – Senior CRA, Lead CRA) PPD (CRO), Kiev, Ukraine
SCRA in global phase III – IV studies. Performed site initiation, interim
monitoring visits; used CTMS system and client specific EDC, SIR distribution
system, Central Lab system. Since April 2015 acted as Lead CRA in the project
which includes MV reports review/approvals, assisted with addressing questions
from local teams, actively participating in CRA, CTMs and Sponsor calls,
performed electronic File review of several counties, performed CTMS/eTMF
compliance with regards to site/country documents;
2006 -2008 CRA (CRAI – CRAII) InnoPharm (CRO), Kiev, Ukraine
Clinical Research Associate on a global phases I-III trials. Performed pre -study,
initiation, interim monitoring and close out visits. Assisted CTM with project
updates and site management. Participated in three Sponsor audits, one
Regulatory inspection and three Compliance Oversight Lead Site visits with
sponsor representative. Accompanied Sponsor representative during booster
site visits. Used RDC for in house eCRF review. Used CTMS. Presented during
Investigator meeting. Participated in 7 data base locks.


2005 -2006 Ultrasound Practitioner / Chelsea and Westminster Hospital, London, UK
Radiology Department, Early Pregnancy Unit and Antenatal Clinic
Performed ultrasound on my own examinations of outpatients and inpatients.
2004 -2005 Trainee Sonographer / Chelsea and Westminster Hospital, London,
UK Radiology Department and Antenatal Clinic . Performed ultrasound
scans under supervision of senior radiologists and sonographers

4
2003 -2004 Health Care Assistant Grade B,C / Nursing and Midwifery Staff Bank
Department, Chelsea and Westminster Hospital, London, Preformed
health care duties. Assisted nurses and doctors in treating patients
2000 -2002 Physician Intern / City Clinical Hospital, Berdichev,Ukraine. Patient
treatment

CLINICAL TRIALS : More than 100 studies as CRA /LCRA , Pfizer partner and Proposal Manager
THERAPEUTIC AREAS: Oncology, Respiratory, Cardiovascular, Pediatrics, Immunization, Infection
diseases, Circulatory, Musculoskeletal, Digestive System, Nervous
System/Sense Organs , Ophthalmology , Medical Device , Women s Health
STUDY TYPES: I, II, III, IV phases; Non -interventional and Registry studies .
ICH GCP TRAININGS : Participated as mentor in 2 sessions for R ussia n Federation Investigator s W ebex
trainings .
AUDITS/INSPECTIONS : Participated in 17 site audits / 4 RA inspections .