Summary
Overview
Work History
Education
Skills
Additional Information
Timeline
Generic

Polina Karelina

Contract Manager
Zwaagdijk-Oost

Summary

Experienced clinical contract manager and financial analyst with 10 years in the pharmaceutical industry, including roles at global sponsors (Bayer, Novartis), a leading CRO (Syneos Health), and an innovative late-phase medical device company (ReCor Medical). Specialized in high-value contract negotiation, budget oversight, and full contract lifecycle management, with a strong focus on collaboration across Clinical Operations, Legal, and Finance teams. Known for translating complex study and operational requirements into clear, practical, and compliant agreements.

Overview

11
11
years of professional experience
5
5
years of post-secondary education
5
5
Languages

Work History

Contracts & Financial Analyst

ReCor Medical
03.2023 - Current
  • Took ownership of the final stages of the clinical contract lifecycle, transitioning from negotiation into execution, payment processing, and financial reconciliation for global studies.
  • Negotiate financial terms in clinical agreements and review incoming invoices, identifying discrepancies and preventing overpayments, achieving measurable cost savings and improving financial oversight.
  • Led the monthly accrual and forecasting process for U.S.-based studies, preparing accurate projections and variance analyses in collaboration with Finance.
  • Improved payment workflows by introducing tracking routines and strengthening collaboration across finance and operations, resulting in more timely and transparent processing.
  • Invented and implemented a standardized PO calculation policy, aligning legal, budget, and operational perspectives to improve consistency across clinical contracts.

Clinical Contracts Specialist (Lead Negotiator)

Syneos Health (inVentiv) - Endo Pharmaceuticals
07.2021 - 02.2023
  • Company Overview: (CRO)
  • Led complex end-to-end negotiations for clinical trial agreements and site budgets across European countries for global Phase II–III studies, ensuring timely Start Up while protecting sponsor interests and regulatory compliance.
  • Acted as lead negotiator and primary liaison between sponsor and site, managing high volumes of concurrent negotiations coordinating closely with sponsor legal, clinical operations, finance, and compliance teams.
  • Drafted, reviewed, and tailored master agreements, CTAs, CSAs, and site-specific templates, aligning with protocol-specific needs, regulatory frameworks, and internal SOPs.
  • Supported internal and external audits, maintaining full audit readiness through contract documentation control and adherence to ICH-GCP and GDPR standards.
  • (CRO)
  • Mitigated risks through the implementation of robust risk management strategies, safeguarding company assets and interests.

Contact manager

Bayer Pharmaceuticals
03.2018 - 06.2021
  • Led a team of contract and budget specialists, overseeing the full contract lifecycle for clinical trials, including procurement, commercial, and service agreements.
  • Designed and implemented a structured contract process that improved transparency, standardization, and compliance across local and regional operations.
  • Developed and maintained a contract management system in close partnership with IT, integrating legal tech tools to streamline workflows and document tracking.
  • Built a comprehensive template library using legal design principles, managing over 340 encoded templates and ensuring regular review, legal alignment, and process efficiency.
  • Delivered legal and compliance trainings to internal teams and served as a mentor for interns, contributing to talent development and compliance culture.
  • Supported green light processes, global audits, and healthcare authority inspections, acting as a subject matter expert in medical law, ethics, and clinical compliance.

Legal Professional (Contract Specialist)

Bayer Pharmaceuticals
01.2016 - 02.2018
  • Drafted, assessed, analyzed and negotiated clinical trial contracts, including their final approval.

Legal Associate

Novartis Pharma
06.2014 - 12.2015
  • Led communications with customers and vendors. Managed and approved sponsorship, grant, donation & membership contracts. Supported contracts for Medical Organizations and HCPs. Approved compliance of publications to legislation and regulatory requirements.

Education

Master in Public Law - Law

MOSCOW STATE UNIVERSITY (MSU)
Moscow
04.2009 - 01.2014

Skills

  • Contract management databases

  • Regulatory compliance

  • Communication skills

  • Contract negotiation

  • Financial analysis

  • Cost savings

  • Legal design

Additional Information

Dutch residence permit with right of work, English, 7.5 IELTS 2021, Dutch, A1 Uitslag basisexamen inburgering, French, DELF B2, Italian, A2, Russian, Native, Proficient with Microsoft Office, Contract management databases and trackers, Deep knowledge of clinical trial process

Timeline

Contracts & Financial Analyst

ReCor Medical
03.2023 - Current

Clinical Contracts Specialist (Lead Negotiator)

Syneos Health (inVentiv) - Endo Pharmaceuticals
07.2021 - 02.2023

Contact manager

Bayer Pharmaceuticals
03.2018 - 06.2021

Legal Professional (Contract Specialist)

Bayer Pharmaceuticals
01.2016 - 02.2018

Legal Associate

Novartis Pharma
06.2014 - 12.2015

Master in Public Law - Law

MOSCOW STATE UNIVERSITY (MSU)
04.2009 - 01.2014

Similar Profiles

CREATE PROFILE
Polina KarelinaContract Manager