Freelancer profile translated to English.
Back to original languageAbout Serge
Senior consultant in Clinical Data Management and clinical systems validation, with over 10 years of experience in pharmaceutical, biotech, CRO, hospital, and institutional environments.
I support my clients on missions for clinical database validation, functional testing of applications (EDC / eCRF), and Computer System Validation (CSV), in compliance with GCP / ICH E6 / CDISC / 21 CFR Part 11 requirements.
My expertise covers the entire clinical data lifecycle:
– eCRF design and validation
– Edit Checks programming and validation
– Database Testing and User Acceptance Testing (UAT)
– Data Cleaning and Data Quality Management
– Database Lock preparation and audit/inspection support
I interact with Data Management, IT, Quality, Statistics, and Clinical Operations teams, with a rigorous approach focused on quality, traceability, and regulatory compliance.
Accustomed to environments subject to audits and inspections, I bring immediate added value to projects requiring data security, system validation, and reliability of clinical deliverables.
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km), Mulhouse (up to 50km), Strasbourg (up to 50km), Annecy (up to 50km), Metz (up to 50km)
Experience
- AXONALSENIOR CLINICAL DATA MANAGER Consultant.BIOTECHSeptember 2022 - December 2022 (3 months)Strasbourg, FranceContext:The consistency tests (edit checks) performed by the client's DM (AXONAL) must be independently reviewed by a second data manager, in accordance with data quality and traceability requirements.I was contacted by Axonal to carry out this independent review of the edit checks, verifying their relevance, consistency, and compliance with protocol specifications and ICH-GCP standards.I was also responsible for reviewing the processes and the data part of all TMF documents.Key Words:- Clinical Database validation and testing- Clinical edit check programming- Clinical Data documents (SOPs, DMP, eCRF, Completion Guidelines)- Review and implementation of Clinical Data processes
- Tempo pharma - SanofiSENIOR CLINICAL DATA MANAGER ConsultantBIOTECHJune 2022 - October 2022 (4 months)Chilly-Mazarin, FranceContext:Sanofi (Chilly-Mazarin site) acquired a product developed by AstraZeneca. All documentation related to this international multicenter clinical study had to be transferred, classified, and archived at the sponsor's site.In this context, I was responsible for co-managing the transfer, classification, and archiving operations of the Trial Master File (TMF) and source documents, in compliance with regulatory requirements and ICH-GCP standards.Furthermore, I designed and implemented an eTMF database independently, to structure, centralize, and secure all study documentation.Key words:- Clinical trials - TMF - Database - Clinical data review- CSV - Monitoring - Data validation
- AB ScienceCLINICAL SYSTEMS AND DATA EXPERT.BIOTECHDecember 2017 - June 2019 (1 year and 6 months)Paris, FranceContext:AB Science obtained Marketing Authorization (MA) for a drug intended for the treatment of a pathology in dogs. Building on this success, the company launched several clinical trial programs in various therapeutic areas, including oncology, hematology, and neurodegenerative diseases (Alzheimer's).In this context, I was in charge of seven clinical trials of different phases. Depending on the study, I acted either as a Clinical Data Manager, responsible for the management and quality of clinical data, or as a Clinical Systems Expert, responsible for the management and optimization of computerized systems used for data collection and management (EDC, clinical databases).Key Words:- E-crf design - Data cleaning - Edit Check programming- Data validation - Clinical System expert - User support- Technical issues systems - User needs Information System
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Education
- Clinical Data ManagementAbsilon-Paris2017Data Management - Gestion de bases de données cliniques: Design des bases de données, Programmation des contrôles de cohérence, Contrôle des Bases de données, Edition des DCFs, codage automatique des données cliniques (WhoDRUG et MedDRA), Contrôles qualité post-saisie. - Rédaction des documents de Data management: Data management Plan : CRF annoté, Dictionnaire des données, plan de validation, guide de saisie, plan de contrôle Qualité, Rapport qualité, Data Review meeting Gestion de Base de données: - CLINSIGHT: Modules Designer, Entry, Confrontator, Test, Coder, Export - SAS BASE: Etape DATA (Set, Merge, Array), Etape PROC (Print, Format, Sort, Transpose) - SAS ENTERPRISE GUIDE 6.1: Programmation sous SAS enterprise + mode assisté - Initiation au MACROLANGAGE: Macro-variable et Macro-programme
- Clinical Research AssociateMediaxe Formation2016GCP, ICH, Recherche clinique, soumissions règlementaires
Certifications
- SASAbsilon2017