Freelancer profile translated to English.

Description

Freelance specializing in clinical and regulatory systems (Veeva Vault eTMF, CTMS, eCRF, RIM). I work with laboratories and IT service companies as an administrator/functional consultant.

My role: to streamline the use and compliance of digital tools in a GxP environment.

With over 8 years of experience in clinical research and computerized systems, I support project teams on access management, evolutionary maintenance, testing (UAT, non-regression), documentation (URS, SOPs), data migration, and user training.

I have worked on several platforms: Veeva Vault eTMF, RIM, PromoMats, Medidata Rave CTMS, eCRF, and various eClinical tools.

Available quickly, autonomous, rigorous, and comfortable in full remote, I can help you to make your tools reliable, strengthen your regulatory compliance, and support your teams in the daily use of your clinical systems.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
Arabic
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

PIERRE FABRE
Veeva Vault RIM & PromoMats Consultant / GxP Business Analyst
May 2025 - Today (1 year and 1 month)
Paris, France
- Responsible for the functional administration and evolution of Veeva Vault systems (RIM & PromoMats) for the Medical Care Business Unit, ensuring GxP compliance and operational efficiency.

> Veeva Vault Administration & Expertise:
Lead Business Administrator for RIM (Regulatory Information Management) and PromoMats domains.
> Veeva Releases Management:
Impact analysis of new functionalities, configuration, and validation before Go-Live.
Workflow configuration and user/security rights management.
> Project Management & Business Analysis (AMOA):
Key interface between Business teams (Regulatory Affairs), IT (DAIS), and Data teams.
Gathering and formalizing business needs (User Requirements) for system evolutions.
Writing test strategies, executing UAT (User Acceptance Testing), and technical documentation.
> Support & Change Management:
Level 2/3 Support: Resolution of critical incidents and functional requests.
Change Management: Creation of training materials and leading sessions for global users.
Maintenance of Quality standards and operational procedures (SOPs) in a regulated environment.
> Technical Environment: Veeva Vault, RIM, PromoMats, GxP, skills=[{
"id": "Veeva Vault",
"type": "GLOBAL",
"name": "Veeva Vault"
}, {
"id": "RIM",
"type": "GLOBAL",
"name": "RIM"
}, {
"id": "eTMF",
"type": "GLOBAL",
"name": "eTMF"
}, {
"id": "Change Management",
"type": "GLOBAL",
"name": "Change Management"
}, {
"id": "Expression de besoin",
"type": "GLOBAL",
"name": "Requirements elicitation"
}]
Veeva Vault RIM eTMF Change Management Expression de besoin
Ipsen Innovation
Clinical System Specialist (Veeva Vault eTMF)
PHARMACEUTICALS INDUSTRY
January 2024 - May 2025 (1 year and 4 months)
Paris, France
Veeva platform and eTMF business admin
• User needs gathering/Writing/Review of URS (User Requirement Specifications)
• Participate in system validation
• Conduct UAT (User Acceptance Tests)
• Participate in SOP review
• Participate in data migration
• User support
• System management after go-live: Access management, Change Management, Release management, Periodic review
• User training
• Update user guides and system documentation, skills=[{
"id": "Change Management",
"type": "GLOBAL",
"name": "Change Management"
}, {
"id": "Support utilisateur",
"type": "GLOBAL",
"name": "User support"
}, {
"id": "User Testing",
"type": "GLOBAL",
"name": "User Testing"
}, {
"id": "Coordination de projet",
"type": "GLOBAL",
"name": "Project coordination"
}, {
"id": "Veeva Vault",
"type": "GLOBAL",
"name": "Veeva Vault"
}]
Change Management Support utilisateur User Testing Coordination de projet Veeva Vault
Sanofi
CSV Consultant
PHARMACEUTICALS INDUSTRY
September 2023 - January 2024 (4 months)
Paris, France
• Review of user needs (URS) and functional specifications (FS)
• Definition of validation strategy and writing of the validation plan
• Facilitation of functional risk assessment workshops
• Writing of the traceability matrix
• Writing of IQ/OQ/PQ test protocols and sheets
• Writing of the validation report, skills=[{
"id": "validation logiciel",
"type": "GLOBAL",
"name": "Software validation"
}, {
"id": "Atlassian JIRA",
"type": "GLOBAL",
"name": "Atlassian JIRA"
}, {
"id": "Atlassian Confluence",
"type": "GLOBAL",
"name": "Atlassian Confluence"
}, {
"id": "Xray",
"type": "GLOBAL",
"name": "Xray"
}, {
"id": "Coordination transverse",
"type": "GLOBAL",
"name": "Cross-functional coordination"
}]
validation logiciel Atlassian JIRA Atlassian Confluence Xray Coordination transverse

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Clinical Operations
De Vinci Executive Education
2017
PhD in Biology
Paris 7
2015

Check out Amine's education

Administer Veeva Clinical Operations
Veeva Systems
2026
Veeva Vault Veeva clinical operations Veeva CTMS Veeva configuration Veeva eTMF
Fundamentals of the TMF Reference Model
CDISC
2026
TMF Reference Model TMF index eTMF CDISC

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Amine Manaa

Veeva Clinical Operations Consultant

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