Project Manager Clinical Research

Vladimir Verbitsky

617-***-**** home 617-***-****

cell

( ******@*****.***

** *** **** ******, ******, MA 02459

EDUCATION

BS in Civil Focused and results oriented Clinical Research Professional

Engineering

Moscow with over 14 years of experience in clinical research, including

Institute of experience in leading, directing, supporting and guiding trial team

members, performing QA audits in clinical research environment.

Civil Engineer Highly skilled in trial planning and analysis with strengths in

Moscow, Russia project management. Resourceful and creative; enjoys challenges and

1981 overcoming obstacles. Recognized for attention to detail and

adherence to standards. While serving as a project manager

achieved repetitive business offers from multiple sponsor companies

Certificate for whom projects were managed.

Program

Moscow School

of

Finance Key Qualifications

Moscow, Russia

1985

Certificate

Program In-depth knowledge of clinical research environment and regulatory

Moscow School requirements governing clinical research trials.

of Management Strong ability to work in a global environment with customers and

Moscow, Russia staff from different countries.

Highly skilled in planning and analysis with key strengths in

1989 project management.

Exceptional attention to detail, adherence to guidelines/standards

and clinical research background.

Continuing

Education and

Certificate Professional Experience

Courses,

including:

Advanced GCP

and ICH

Guidelines Project Manager/QA Auditor: Geny Research Corp. Newton, MA-Moscow,

Compliance; Russia 2003-11/2014

Optimizing

Pharmaceutical Served as a Project Manager and QA Auditor handling multiple

Project clinical trials.

Management; Acted as liaison between the Investigators Sites, Project Team

Good Members, Sponsors, CROs and their affiliates.

Documentation Lead, directed, supported and guided the Trial Team Members to

Practice; ensure study delivery on time, on budget and in appropriate

Increasing the quality.

Likehood of Supervised correspondence with pharmaceutical companies/sponsors

Successful and their affiliates.

Clinical Trial; Monitored quality and timelines of data submissions.

How to survive Performed Internal Audits.

the FDA Prepared presentations for Investigator Meetings.

Inspection; and Updated Company brochure and website.

others Wrote/Designed Protocol, CRF and other study related documents.

Full list Developed company's SOPs.

available upon Handled numerous projects reporting directly to the CEO and

request President of the company.

SKILLS Clinical Research Associate: Geny Research Corp. Newton,

MA-Moscow, Russia 09/2001-2003

Knowledge of

FDA,ICH, GCP Supported the Trial Team Members to ensure study delivery on time,

and other on budget and in appropriate quality

regulatory Supervised correspondence with pharmaceutical companies/sponsors

requirements and their affiliates

and guidelines; Acted as liaison between the Investigators Site, Project Team

Members, Sponsors, CROs and their affiliates

Monitored quality and timelines of data submissions

Proficient in Prepared presentations for Investigator Meetings

Windows, Updated Company brochure and website

including Wrote/Designed Protocol, CRF and other study related documents

Microsoft Developed company's SOPs

Office and

other relevant

applications

CRC/ Clinical Trial Coordinator: Geny Research Corp Newton, MA

Fluent Russian 01/2000-09/2001

Moscow, Ru

Clinical trial coordination for multiple sites and projects

including, but not limited to:

Managed patient recruitment/retention

Performed informed consent process, patients' visits, vital signs

assessments, and phlebotomy

Managed collection, documentation and maintenance of clinical data

while ensuring compliance with study protocols

Maintained of regulatory documents

Reported adverse events in a timely manner

Corresponded with Sponsor, IRB, and Investigators

Managed specimen handling and shipping

Performed other administrative tasks in support of conducted

clinical studies

General Manager: GGC Worldwide Ltd.

Burlington, MA 11/1996- 01/2000

Office Manager: GGC Worldwide Ltd.

Burlington, MA 09/1992- 11/1996

Manager Trainee: GGC Worldwide Ltd.

Burlington, MA 06/1991- 09/1992

Full lists of research experience and references are available upon request

Contact this candidate