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GlaxoSmithKline
- Head of Statistical Analysts, Biostatistics
Marly-le-Roi
2014 - maintenant
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GlaxoSmithKline
- Senior Manager, Quality Practices, Clinical Data Management
Marly-le-Roi
2012 - 2014
•Accountable for Data Management processes across all functions within the Data Management department:
-Ensure that processes are defined and duly documented: involvement in definition, documentation, implementation and improvement of the “How” in Data management,
-Check the application of the DM processes by the relevant functions by conducting a regular quality controls,
-coordinate the trainings of the DM functions
-Support DM Portfolio teams in resource management (resource forecasts, recruitments, site management, in and out-sourcing)
-Maintain the DM standard documents and templates: CRF, annotated CRF, Data base structure, DM and Stats SAS macros …
-Support our customers in DM activities during all phases of clinical studies
•People management in Belgium and India: Quality Practice Leaders (4), Quality Practice Managers (5), Quality Practice Specialist (1), Data Standard Programmers (7), DM and Stats Data Standard Analysts (5), Data Base Administrators (4) and CRF Designers (4)
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GlaxoSmithKline
- Senior Manager, Study Set-Up, Clinical Data Management
Marly-le-Roi
2011 - 2011
•Accountable for Clinical Data Management studies Set-Up:
-Define standards used across all GSK Biologicals clinical and epidemiological studies: standard CRF and related software programs to clean, monitor and report data.
-Co-leader of a multi-disciplinary taskforce defining standard protocol and CRF.
-Global ownership of the SOPs, documentation, processes and good practices followed by Data Standards Programmers and Study Set-Up Programmers.
-Establish state-of-the-art processes to implement standard requirements in CRF and related software programs to clean, monitor and report data as well as their customization to study-specific requirements.
-Deliver the mission according to business priorities and in compliance with good clinical practices (GCP), GSK policies and SOP
-Interface with GSK Biologicals Project Teams in a matrix environment
-Responsible of the CRF design of GSK Biologicals funded studies
-Responsible of the customization of study-specific data collection tools and related computer programs to clean, monitor and report data.
-Provide Data Management expertise in multi-disciplinary taskforces of process improvements
•People management in Belgium and India: DM Study Set-Up staff represents 34 (4 direct reports, 16 GSK headcounts, 14 in-sourced CROs))
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GlaxoSmithKline
- Head of Data Management and Logistics Unit
Marly-le-Roi
2006 - 2011
Head of Data Management activities for GSK France and the European Centre of Excellence:
•Guarantee the reliability & the quality of the subjects data of the clinical & epidemiological studies,
•Define the local & international needs: elaboration of specifications, negotiation of the estimates, selection of the CROs, contracts elaboration, projects management, deliverables validation and performances follow-up.
•Set up innovative solutions according to the objectives, budget constraints & design of the projects,
•Manage the CROs: implementation of a privileged partnership with the CROs: audit of the Data Management processes, quality control of GSK France and Corporate deliverables,
•Manage the projects budgets: negotiation, invoices validation, contract amendments
•Facilitator between the Corporate teams & the local or regional CROs,
•Responsible for the elaboration & maintenance of the procedures of the Data Management activities,
•Write Data Management Training Material
•Develop a Data Management Centre of Excellence for the PAN European projects.
•Privileged Contact of the Corporate & the others Local Operating Companies for the Data Management & logistics activities.
Head of Logistics activities for GSK France and Corporate projects:
•Responsible for the deployment in France of the systems used by the Medical Direction,
•Expert of the systems used by the Medical Direction: study management, site initiation, investigators sites training, GSK and CROs staff training, CRF elaboration, subjects data collection, SAEs notification, study drugs shipment, subjects randomisation, SAEs and drugs coding, studies transparency (Publication of the protocols and results summaries), NDA and IND annual Reports management for the FDA.
•Responsible for the Medical Direction staff trainings Concerning the medical tools and applications,
•Guarantee the reliability and the quality of the studies data
•Management of Logistics Technicians
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WHO
- Data Management consultant
2006 - 2008
Consultant and auditor for the WHO :
•Audit of the Data Management and Statistics department of « Second Military Medical University » in Shanghai in China: http://www.cdmtdr.org/index.php?group=main&open=china.php
•Audit of the Data Management et Statistics of « Christian Medical College » in Vellore in India: http://www.cdmtdr.org/index.php?group=main&open=india.php
•Audit preparation of the Data Management et Statistics of « Faculty of Medicine Siriraj Hospital » in Bangkok in Thailand,
•Consultant for the Data Management Activities and Clinical Research: support and advice for the Monitoring, pharmacovigilance and Data Management activities.
Participation to the Annual Clinical Pharmacology workshop of GIENS 2009 : « Clinical Studies and e-Health »
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GlaxoSmithKline
- Clinical Data Management Coordinator
Marly-le-Roi
2003 - 2006
•Set up of the Full out-sourcing of the GSK France Data Management activities,
•Manage the CROs deliverables,
•Interface between the French Medical Direction teams and CROs,
•Coordinate the GSK France Data Management activities,
•Responsible for the Data Management budgets: CROs estimates negotiation, Data Management contracts elaboration and invoices validation,
•Implement the Data Management activities indicators and metrics,
•Validate the Data Management procedures, policies and standard documents (Local and international),
•Privileged Contact of the Corporate and the others Local Operating Companies for the Data Management activities.
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GlaxoSmithKline
- Business Units Data Management Head
Marly-le-Roi
2001 - 2003
of Vaccines BU, Infectiology-Cardiology-metabolism BU and Central Nervous System BU.
•Manage 4 therapeutic Area Data Managers : training, projects deliverables follow-up, business and technique support, facilitator between the in-house and external staffs and the Data Managers,
•Manage projects of the BUs portfolio studies: Studies documents elaboration, databases set-up, subjects data cleaning, projects indicators and metrics follow-up, databases release and Clinical Study Report writing participation.
•Validate the budgets of the BUs portfolio studies and the management of the corresponding invoices,
•Validate the procedures and the standards documents (CRF, structure of databases and data validation specifications),
•Manage the out-sourcing activities: requests for proposals, CROs selections, BIDs negotiations, contract elaboration, deliverables validation,
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GlaxoSmithKline
- Senior Data Manager
Marly-le-Roi
1997 - 2001
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Neuroscience Laboratory u2013; CNRS URA 1829, University of Caen
- Biologist
1995 - 1996
•Conception & achievement of pharmacological study about the opiodergic receptors.
•These results were published in Journal of Neurochemistry review: “THE delta-OPIOID RECEPTOR IN SK-N-BE HUMAN NEUROBLASTOMA CELL LINE UNDERGOES HETEROLOGOUS DESENSITIZATION”.
