Kais G.

Clinical Site Contracts and Budgets Lead, with solid experience in end-to-end contract and budget negotiation for clinical trials within CROs and sponsor environments (FSP model). Through my proven cross-functional collaboration with both local and international stakeholders, I bring strong skills in proactive problem-solving, compliance, quality focus, and managing complex escalations under pressure.

My previous experience as a Site Activation Project Manager strengthened my understanding of the full clinical study lifecycle and the interconnection between each phase, stakeholder, and deliverable — and how contract execution directly impacts site initiation timelines and patient recruitment performance.

I prepare, negotiate, and finalize agreements with participating hospital sites, ensuring alignment with operational needs, regulatory requirements, and study timelines.

Finally, my strong IT experience in CRO, fluency in digital tools, and my Lean Six Sigma certification focused on process optimization, bring added value through streamlined, efficient, and scalable operations

Expérience professionnelle 1

Sr Manager, Contracts

ICON Plc

Home Based Paris, Île-de-France, FRA

From: 2023-09 À 2025-10

Role Description:

• Negotiate sites Contracts and Budgets for complex studies.
• Lead cross-Functional Team (Contract negotiators, Payment Associates, CTAs et SSU Associates) 
• Onboard new contract negotiators and mentor junior ones
• Oversee pCROs and contract negotiators to ensure timely contract delivery at Regional Level
• Working in an agile environment with cross-functional teams like interaction with legal services, to ensure compliance with internal and external requirement 
• Anticipation of risks related to contract execution and budgeting before site selection and throughout ongoing studies.

Expérience professionnelle 2

Sr Manager_Investigator contract Lead 3 (ICL3)

ICON Plc _ Pfizer FSP

Home Based Paris, Île-de-France, FRA

From: 2023-02 À 2023-08

Role Description:

• Oversee and Lead regional contract negotiations of CROs on behalf of Clients, including cross-functional coordination for timely resolution of escalations, budget challenges, and accelerated contract timelines. 
• Oversee Budget&Site payments and coordinate development of Per Subject Costs (PSC) for assigned studies. 
• Serve as primary escalation point for pCRO regarding site contracting issues. 
• Facilitate cross-functional collaboration to resolve contracting challenges Lead sponsor/pCRO governance meetings focused on timelines, compliance, and escalation management.

Expérience professionnelle 3

Investigator contract Lead _ Pfizer FSP

ICON Plc _ Pfizer FSP

Home Based Paris, Île-de-France, FRA

From: 2021-03 À 2023-01

Role Description:

• Led end-to-end contract and budget activities, including developing contract execution strategies and communicating effectively with study teams. 
• Directly negotiated Clinical Study Agreements (CSAs) and ancillary documents with investigative sites. 
• Facilitated and led kick-off meetings for contract management, aligning closely with Site Start-Up (SSU) activities to ensure readiness. 
• Collaborated proactively with Legal and cross-functional teams for timely escalation management and issue resolution. 

Expérience professionnelle 4

Contract Manager_ Gilead FSP

ICON Plc _ Gilead FSP

Home Based Paris, Île-de-France, FRA

From: 2019-01 À 2021-03

Role Description:

• Led contract and budget negotiations with clinical sites and institutions (Phases II–IV studies), primarily for France, with additional support for Belgium, Sweden, and the Netherland. 
• Acted as Single Point of Contact (SPOC) for cross-functional coordination (SSU, Legal, Management). 
• Managed ad-hoc international contract negotiations and communications, notably for COVID-19 studies across France, Belgium, and the Netherlands. proactive legal coordination.
• Led contract negotiations for over 20 critical COVID-19 studies, ensuring rapid site activation during the pandemic. 
• Served as the lead negotiator for the highest-recruiting sites in Gilead’s oncology and virology portfolio, directly impacting study success and patient enrolment.

Expérience professionnelle 5

Site Activation Associate provides services to Eli Lilly and Company

ICON Plc

NEUILLY-SUR-SEINE

From: 2016-02 À 2018-12

Role Description:

• Led global study start-up activities and ensured site readiness for patient enrollment. 
• Coordinated with cross-functional teams to align start-up deliverables and timelines 
• Provided historical site activation data to inform optimal site selection strategies 
• Prepared and updated site/country-specific ICFs in response to protocol amendments and risk updates. 
• Managed EC submission packages, including review, approval, and translation processes.
•  Acted as Country Trainer for France on ISAM database usage and compliance. 
• Negotiated clinical trial agreements with institutions and investigators, in collaboration with regional and global SRPs.
•  Managed both the submission and the contract negotiation and Reduced site activation timelines by 30% by leveraging historical data for better site selection. 
• Activated over 60 sites, with 20% reaching recruitment readiness ahead of schedule. 
•  Developed training programs for 3 countries (France, Belgium, UK), improving database efficiency and contract workflow understanding.

Expérience professionnelle 6

Senior Clinical trial coordinator

CLINTEC INTERNATIONAL PROVIDES SERVICES TO MSD

Paris, La Defense, FRA

From: 2015-01 À 2015-09

Role Description:

• Responsible for negotiating and coordinating contract work across multiple Contracts Specialists and subcontractors (supervise contract negotiations performed by Partner CRO
•  Responsible for examining Study documents to ensure completeness and accuracy, as well as conformance to applicable laws, rules, company and customer requirements. 
•  Reduced payment processing errors by 95%, ensuring accurate site and patient reimbursements. 
• Standardized contract templates, leading to a 20% reduction in negotiation time per site.

Expérience professionnelle 7

Country Clinical Trial Assistant

Quintiles

LEVALLOIS PERRET

From: 2010-12 À 2014-07

Role Description:

Administrative management with regulatory submission to the competent authorities. Supported global Clinical Project Managers (CPMs) in Phase II–III trials across Oncology, Dermatology, Endocrinology, and Rheumatology. Managed regulatory submissions to competent authorities, ensuring alignment with timelines and compliance requirements. Participated in internal and external audits, assisting with issue resolution and documentation follow-up. Conducted co-monitoring visits to address data backlog, site compliance, and quality concerns.

• Reduced clinical trial database errors by 80%, improving data quality and audit readiness.

• Participated in co-monitoring visits, directly improving site compliance and data integrity.

• Resolved findings in internal and external audits within my Scope, ensuring Roche’s continued regulatory compliance.

Expérience professionnelle 8

IT & Technical Support Specialist

Hewlett Packard

Paris France

From: 2006-05 À 2010-12

Role Description : 

Responsibilities Provided IT support, technical troubleshooting, and systems management, significantly enhancing operational efficiency and ensuring rapid resolution of technical issues.

Clinical Site Contracts and Budgets Lead, with solid experience in end-to-end contract and budget negotiation for clinical trials within CROs and sponsor environments (FSP model). Through my proven cross-functional collaboration with both local and international stakeholders, I bring strong skills in proactive problem-solving, compliance, quality focus, and managing complex escalations under pressure.

My previous experience as a Site Activation Project Manager strengthened my understanding of the full clinical study lifecycle and the interconnection between each phase, stakeholder, and deliverable — and how contract execution directly impacts site initiation timelines and patient recruitment performance.

I prepare, negotiate, and finalize agreements with participating hospital sites, ensuring alignment with operational needs, regulatory requirements, and study timelines.

Finally, my strong IT experience in CRO, fluency in digital tools, and my Lean Six Sigma certification focused on process optimization, bring added value through streamlined, efficient, and scalable operations