Summary
Overview
Work History
Education
Skills
Websites
Certification
Languages
Timeline
Generic

Olga Chernyak

Westfield,IN

Summary

Experienced with operational process improvements and streamlining workflows for efficiency. Utilizes strong problem-solving skills and collaborative approaches to meet organizational goals. Track record of effective resource management and implementing best practices for operational success.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Clinical Trial Operations Specialist

Boehringer Ingelheim (BI)
Indianapolis, Indiana
08.2021 - Current
  • Acted as the primary point of contact for site staff, addressing trial-related inquiries throughout the planning, conduct, and closure phases to ensure seamless communication and operational alignment.
  • Oversaw all site start-up and conduct activities, including management of contracts, regulatory and essential documents, informed consent updates, training coordination, and investigational product supply readiness.
  • Directed site logistics by reviewing, distributing, and tracking site documents and materials such as protocols, ICFs, and trial supplies to ensure timely and accurate site preparation.
  • Maintained trial-specific databases and trackers (e.g., IVRS, CTMS, Veeva Vault, Clario, LabCorp portal), performed monitoring trip report reviews and signoffs, and served as CAPA lead for issue identification and resolution.
  • Led trial documentation efforts by developing site-facing communications (e.g., newsletters), managing vendor interactions, and proactively monitoring site recruitment and patient retention metrics.
  • Analyzed performance metrics to identify trends and facilitate data-driven decision-making.
  • Collaborated with cross-functional teams to ensure alignment on project goals and deliverables.
  • Conducted regular audits of operational procedures to ensure compliance with industry standards.
  • Oversaw day-to-day operations, delegating tasks appropriately to ensure smooth workflow and timely completion of projects.
  • Successfully managed multiple projects simultaneously while adhering to deadlines and budget constraints.
  • Optimized supply chain logistics to improve delivery times and reduce transportation costs.

Clinical Monitoring Associate

Syneos Health (formally inVentiv Health)
Indianapolis, Indiana
09.2018 - 08.2021
  • Served as the primary remote contact for project site personnel in collaboration with on-site CRAs, managing site qualification, initiation, monitoring (SMCs), and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
  • Ensured site readiness and compliance by training site teams, verifying adherence to the Clinical Monitoring Plan, and overseeing investigational product (IP) receipt, storage, and handling in alignment with study protocols.
  • Maintained oversight of subject recruitment and retention efforts while managing document collection, TMF reconciliation, and real-time remote data review to uphold accuracy, timeliness, and completeness of study records.
  • Executed site-level data monitoring through RADaR tools, addressed data issues proactively, and tracked site performance metrics to implement corrective action plans as necessary.
  • Produced essential trial documentation, including confirmation and follow-up letters and SMC reports while holding IAOCR Central Monitor certification and applying quality standards across all monitoring activities.

Country Submission Specialist

Syneos Health (formally inVentiv Health)
Indianapolis, Indiana
09.2017 - 04.2018
  • Supported Clinical Operations teams by completing essential tasks that advanced departmental and project goals across regulatory and operational workflows.
  • Delivered study-specific documentation and guidelines to project teams, ensuring clarity, consistency, and compliance with protocol standards.
  • Organized and maintained clinical trial documentation, preparing for internal and external audits, overseeing final reconciliation, and managing archival processes.
  • Facilitated site communication by responding to documentation requests and assisting with quality control audits to verify completeness and regulatory readiness.

Interim Clinical Research Coordinator

Rehabilitation Associates of Indiana
Indianapolis, Indiana
11.2014 - 01.2015
  • Developed Standard Operating Procedures to guide clinical study operations and ensure regulatory compliance throughout all trial phases.
  • Conducted eligibility screenings via phone interviews and scheduled intake appointments to support subject recruitment and enrollment.
  • Managed clinical documentation by maintaining source records, regulatory files, and subject data while ensuring CRF accuracy and protocol adherence.
  • Monitored subject safety and compliance through regular follow-ups, documented adverse events for investigators and sponsors, and maintained a study database to track participant data and shipment activity.

Senior Consultant / Project Manager

CSpring - Hewlett-Packard / Indiana Dept of Medicaid
Indianapolis, Indiana
02.2013 - 05.2013
  • Conducted stakeholder interviews and developed business cases to identify and implement process improvements that aligned with project goals and client needs.
  • Developed comprehensive training materials and documentation and delivered client instruction to ensure seamless adoption of new procedures and systems.
  • Planned and facilitated project team meetings, managed team schedules, and mentored members to enhance skills and maintain alignment throughout the project lifecycle.
  • Led the successful design and delivery of the Indiana Medicaid provider portal project, completing it within a two-month timeline while overseeing all phases from initiation through execution.

Project Manager

Roche Diagnostics (DSS contract for Eli Lilly & Co. / Convance)
Indianapolis, Indiana
07.2006 - 07.2012
  • Maintained project schedule and documentation for the project in compliance with the policies of Eli Lilly.
  • Managed a marketing research project for an oncology reseach department in U.S. and France.
  • Managed project schedules and timelines for phase II-IV clinical trials, ensuring alignment across internal teams and external laboratory operators.
  • Coordinated end-to-end laboratory processes by fostering collaboration between Covance and pharmaceutical/ biotech sponsors, maintaining consistent communication to drive protocol adherence.
  • Directed complex logistics for over 10,000 biological samples, orchestrating their transfer from multiple North American storage sites to the Indianapolis Central Lab within two weeks, ensuring full regulatory compliance.
  • Supported sponsors with laboratory data access and data management, helping maintain data integrity and availability throughout the trial lifecycle.

Education

Master of Science in Health Science (MSHS) -

Cleveland State University
Cleveland
2006

Master Of Business Administration - Healthcare Administration and Project Management

DeVry University - Keller Graduate School of Management
Columbus
2005

Bachelor of Science - Biological Sciences

The Ohio State University
Columbus, OH
1999

Skills

  • Operational efficiency
  • Planning and coordination
  • Cross-functional communication
  • Project management
  • Operations coordination
  • Risk mitigation
  • Resource planning and scheduling
  • Process documentation
  • Teamwork and collaboration

Certification

Green Belt License / CMIACR Qualified Clinical Research Central Monitor / GCP certification

Languages

Russian
Native or Bilingual
English
Native or Bilingual

Timeline

Clinical Trial Operations Specialist

Boehringer Ingelheim (BI)
08.2021 - Current

Clinical Monitoring Associate

Syneos Health (formally inVentiv Health)
09.2018 - 08.2021

Country Submission Specialist

Syneos Health (formally inVentiv Health)
09.2017 - 04.2018

Interim Clinical Research Coordinator

Rehabilitation Associates of Indiana
11.2014 - 01.2015

Senior Consultant / Project Manager

CSpring - Hewlett-Packard / Indiana Dept of Medicaid
02.2013 - 05.2013

Project Manager

Roche Diagnostics (DSS contract for Eli Lilly & Co. / Convance)
07.2006 - 07.2012

Master of Science in Health Science (MSHS) -

Cleveland State University

Master Of Business Administration - Healthcare Administration and Project Management

DeVry University - Keller Graduate School of Management

Bachelor of Science - Biological Sciences

The Ohio State University

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