Summary
Overview
Work History
Education
Skills
Language Capabilities
Timeline
Therapeutic Experience
Generic

Guy Gerson

Tel Aviv

Summary

Contract Specialist with extensive experience in managing CRO and site contracts. Adept at optimizing contract negotiations while ensuring compliance with regulatory standards. Highly skilled in reviewing and negotiating site contracts, budgets, financial agreements and ancillary documents, while identifying potential issues and implementing strategies that mitigate risks. Committed to upholding high standards of quality and compliance.

Overview

9
9
years of professional experience

Work History

Site Readiness and Regulatory Senior Specialist

Fortrea
06.2023 - 05.2025
  • Review and negotiate site contracts, ancillary agreements in accordance with defined processes and time frames. Liaise and communicate with corporate Legal, Contract and Finance departments when appropriate. Provide accurate guidance to queries regarding the financial payment arrangements/processes and legal obligations of the site contracts.
  • Responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements.
  • Ensure appropriate systems are updated accurately and compliantly, ensuring others follow established processes
  • Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required
  • Mentor and coach other Site Readiness and Regulatory Operations team members
  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
  • Participate independently and take lead (as applicable) in client meetings to proactively liaise on issues related to site activation and maintenance
  • Proactively identifying, preventing and escalating to Submission Leads any risk to meeting deliverables and participate in strategy meetings to mitigate them

Site Readiness and Regulatory Specialist II

Fortrea (Formerly Labcorp)
06.2021 - 05.2023
  • Review and negotiate site contracts, Budgets and ancillary agreements in accordance with defined processes and time frames

Associate Contract Specialist

PPD
02.2020 - 05.2021
  • Performs and coordinates all activities required to finalize site contracts (including, contractual terms and conditions, associated investigator grant budget(s), payment schedule terms and conditions and ancillary documents), with investigator sites, pharmacies, laboratories, or other relevant contractual parties during the lifecycle of the study.
  • Reviews CRO and/or client site contract templates for compliance with local legislation and practices. Adapts site contract template to client and investigational site requirements in collaboration with key stakeholders to include the project team and the CRO legal team.
  • Serves as contact with investigative sites for contractual issues and negotiations throughout the lifecycle of a study. Assumes responsibility for any ongoing contract or budget amendments.

Senior Site Activation Coordinator

PPD
04.2019 - 01.2020
  • Provides senior level administrative support for site activation activities. Supports the development of the critical path for site activation within assigned projects to provide support for rapid site activations.

Site Activation Coordinator

PPD
08.2016 - 03.2019
  • Provides technical and administrative support and coordination for projects in collaboration with relevant internal departments and team members to support alignment of site startup activities and the achievement of project target cycle times for site activations.
  • Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Assists with the preparation of regulatory compliance review packages, as applicable, which may include working directly with sites.
  • Liaises locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
  • Assists in developing country or site-specific documents.

Education

Bachelor of Arts -

Tel Aviv University
Tel Aviv
2007

Skills

  • Attention to detail
  • Teamwork and collaboration
  • Communication skills
  • Dependable and responsible

Language Capabilities

Hebrew
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)

Timeline

Site Readiness and Regulatory Senior Specialist

Fortrea
06.2023 - 05.2025

Site Readiness and Regulatory Specialist II

Fortrea (Formerly Labcorp)
06.2021 - 05.2023

Associate Contract Specialist

PPD
02.2020 - 05.2021

Senior Site Activation Coordinator

PPD
04.2019 - 01.2020

Site Activation Coordinator

PPD
08.2016 - 03.2019

Bachelor of Arts -

Tel Aviv University

Therapeutic Experience

  • Oncology, Phase I-III
  • Ophthalmology, Phase III
  • Cardiology, Phase III
  • Hematology, Phase IIb
  • Endocrinology, Phase II, III
  • Respiratory, Phase III
  • Infectious Diseases, Phase III

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Guy Gerson