Костянтин

Curriculum Vitae
KOSTIANTYN YAFAIEV

Personal
Name Kostiantyn Yafaiev
Location Kyiv, Ukraine
Cell [відкрити контакти](див. вище в блоці «контактна інформація»)
Email [відкрити контакти](див. вище в блоці «контактна інформація»)
Date of birth 07 Jan 2000
LinkedIn Kostiantyn Yafaiev

Profile
Results-driven Operations & Compliance Specialist with over 5 years of experience managing
complex operational workflows, regulatory compliance, and cross-functional processes within matrix
global organizations. Proven track record of managing operational support for 5–7 concurrent
projects and 60+ trial sites/locations. Expert in building end-to-end tracking systems (Single Source
of Truth), executing large-scale process audits (4+ years reconciliation), and performing financial
quality checks. Experienced in operating under a Dual-Compliance framework for both vendor and
end-client (Big Pharma — MSD). Seeking a high-impact Operations / Project / Compliance
Coordinator role in technology, Defense-Tech, or enterprise sectors.

Languages
Ukrainian – native.
English – B2+ / Professional working proficiency.

Key Competencies & Core Skills
Operations & Project Support: Process Architecture & Digitization:
Multi-project coordination (5–7 protocols, 60+ Designing end-to end tracking tools (Single
sites), milestone tracking, operational workflow Source of Truth) bridging regulatory, financial,
management. and eTMF data.
Dual-Compliance Execution: Institutional Verification (Facilities):
Simultaneous alignment with KPIs, corporate Verification of site eligibility, licenses,
standards, and training requirements of two accreditations, institutional structure, and
corporate entities. Essential Documents.
Regulatory Intelligence: Data Audit & Reconciliation:
Portfolio-wide tracking of Ministry of Health 4-year regulatory archive audits, data cleansing,
(MoH) decrees, verifying project impact, and identifying Data Privacy Agreements errors,
advising cross-functional teams. duplicate accounts, and system discrepancies.
Stakeholder Management (PoC): Financial Quality Control:
Serving as the main Point of Contact for 60+ In-house reconciliation of financial tools,
sites in projects, external partners, and local contracts, and agreements to eliminate
ethics committees (LEC/SEC). deviations.

Professional Experience
Senior In-House Operations & Compliance Coordinator / CTA Jul 2021 – Present
MSD (Merck Sharp & Dohme Corp.) (via FSP Partners: Fortrea / Splendidscore / Manpower) — Kyiv,
Ukraine

• Fortrea Stream (formerly Labcorp) Jan 2024 – Present
Multi-Site Project Operations: Managed operational logistics for 5–7 active protocols
across 60+ medical sites, ensuring zero deadline overruns and 100% regulatory compliance.

Kostiantyn Yafaiev CV Page 1 of 2

Curriculum Vitae
KOSTIANTYN YAFAIEV
Dual-Compliance Management: Maintained high operational output while fulfilling parallel
KPIs, mandatory trainings, and corporate compliance standards for both Fortrea and MSD.
Institutional Site Verification: Collected, verified, and audited complete
legal/administrative site packets (licenses, accreditations, internal decrees, DPA
agreements, CVs, and Essential Docs) to secure site launch readiness.
LEC Submissions & Adaptation: Adapted, localized, and submitted regulatory packages to
60+ Local Ethics Committees (Initial, Substantial Amendments, Notifications, Reports).
Quality Control: Executed internal financial quality checks, auditing financial tools and
vendor agreements to detect and eliminate discrepancies. Cleansed DPA registries,
eliminating critical account duplicates and documentation errors.
System Administration & eTMF: Maintained site status in CTMS platforms (Veeva Clinical,
Spectrum), managed eISF, and ensured audit-ready electronic archives.

• Splendidscore / Manpower Stream Jul 2021 – Dec 2023
Regulatory Orders & Portfolio Tracking: Monitored and verified all MoH Decrees across the
entire project portfolio, ensuring swift operational alerts and team alignment.
Process Automation (Single Source of Truth): Designed and implemented an Excel-based
tracking framework bridging regulatory submissions, approvals, financial invoices, and eTMF
links.
4-Year Data Reconciliation & Cleansing: Conducted a comprehensive audit and
reconciliation of regulatory archives for 2020–2023, identifying and fixing critical system
discrepancies and missing compliance records.

Education & Qualifications
Master’s Degree: Quality, Standardization, and Certification — National University of Pharmacy,
Kharkiv
Bachelor’s Degree: Enterprise Economics — Kyiv National University of Trade and Economics, Kyiv

Software & Enterprise Systems
Clinical & ERP Systems: Veeva Vault (eTMF), Spectrum/Veeva Clinical (CTMS), CLMS/eFDS
(management systems – disclosure forms, learming), SIP, Florence (eISF).
Tools & Analytics: MS Office, AI agents, Adobe.

Kostiantyn Yafaiev CV Page 2 of 2