Project Manager Assistant

Location:

Posted:

July 06, 2014

Professional Summary

Motivated Associate with more than 3 years in project management in the

clinical trials industry. Offers an in-depth understanding of project

lifecycles and project development methodologies. Fluent in Russian and

Ukrainian.

Professional Experience

Site Intelligence and Activation Associate Pharmaceutical Product

Development, CRO

Kiev, Ukraine

May 2012 - September 2013

. Managed all aspects of clinical trials projects and maintained

responsibility for the planning, execution, tracking, delivery and closure

of such projects, using PPD standard processes and tools.

. Monitored timelines and flagged potential issues to be addressed.

. Managed activities associated with obtaining initial and amended

regulatory authority approvals from the State Expert Center, Central and

Local Ethics Committee, Ministry of Health including periodic notifications

and reporting to Regulatory Authorities.

. Responsible for delivering weekly project reporting on overall program

progress, individual project status, resource availability.

. Implemented comprehensive tracking processes to monitor timely execution

of each stage of the project.

. Prepared clinical trial site documentation

. Performed translations or oversaw translation vendors to ensure

translations and back-translations adhered to study requirements.

. Interacted effectively with the Sponsors of the trials, CTMs, PMs,

Project Leads in order to coordinate and facilitated documentation required

for submissions, ensuring that it complied with country requirements, ICH-

GCP, the trial protocol and filed trial related documents in the electronic

repository.

. Mentored other associates in process.

Regulatory Affairs Assistant Pharmaceutical Product

Development, CRO

Kiev, Ukraine February 2012

- May 2012

. Provided administrative support including preparation of submissions,

entering information into databases, distribution of regulatory information

to the team members and helped to coordinate meetings.

. Responsible for proofreading, copying, filing and archiving submission