François-Michel - Consultant CRYSTAL REPORT

QA IT Compliance Senior Expert

In the scope of the Novartis Vaccins integration program, QA oversight for the 35 IT R&D projects of the program:
 Advise and orient as IT Quality Officer each Business Unit whatever the Computer Related System category: Clinical, Regulatory Affairs, Discovery
 Manage the supervision of IT and Analytical & Automated systems Validation Projects (integration, lift & shift and contract switch projects)
 Reporting, KPI definition and follow-up, Risks & Issues management
 Transversal risks analysis for R&D systems Data Migration
 Contribution to Program Validation Master Plan (Master VMP) definition and maintenance
 R&D projects Validation Documentation review to ensure conformance with IT Quality and Validation process

Project Manager

Project Manager for the deployment of a Clinical Data Management System (CDMS) in the scope of Sanofi/Sanofi Pasteur/Genzyme Information Systems convergence program (UNIFY):
 International environment (France, US, UK, India, China)
 Coordination of Sponsors, Business Project Leads, Subject Matter Experts, Business Analysts, IT Project Leaders
 Management of planning, dependencies, risks/issues
 Reporting for UNIFY PMO: milestones, KPI, scorecards
 Study Setup, Study Conduct and Study Lock processes definition (Lean Six sigma)
 Conduct of meetings (Steering Committees , Core Team Meetings, Process Meetings, Ad-hoc meetings)
 Transversal communication with other program Streams (Processes Coordination, Change Management, CTMS, User & Access Management, Reporting/Dashboards)

Design and development of an application for insurance agents requests tracking, for QUATREM (MALAKOFF MEDERIC group) Front Office IS department:
 ASP.NET project : design, development, technical tests, release
 Users training in Quatrem regional offices

IS Project Leader

Functional and detailed specifications (Medidata RAVE, iMedidata, Coder, RSB, TSDV)
 IT Teams coordination (Infrastructure, SSO/Federation, Performance Testing)
 Management of System Integration Testing in GxP environment

Project Director

Lead for the setup of a platform dedicated to investigators and hospital expenses payment, for Clinical Studies partially subcontracted to CROs by ROCHE.
 Sponsor-CRO collaborative portal
 Calculation of investigator payments and hospital expenses, automated generation of invoices and payments
 Audit and lead for the development of the platform
 Functional workshops, UAT phase coordination, trainings

Project Manager (Mission: 15 months)

Project Manager for the setup of an interface between Caisse des Dépôts Private Equity solution (eFront/ISIS) and accounting system (CEDRE).
 Project stakeholders coordination (MOA, Vendor, IT teams)
 Planning, risks management
 Organization and conduct of meetings (Steering Committees, Project Team meetings)

- PMO (Mission: 6 months)

Setup of a local PMO cell (2 people) for monitoring the budget of ACFI/PCG/PJT’s project portfolio.
 International environment (FR, US, UK, EMEA, Asia)
 Definition and setup of a local PMO process for the 5 entities of ACFI/PCG/PJT
 Strategic reporting (key indicators) for ACFI/PCG governance
 Integration of HPPPM solution in the business entity (users trainings, support for vendor’s consultants)

Project Manager (Mission: 12 months)

Management of two migration projects around the Altaix Real Estate solution.
 Organization and conduct of meetings and workgroups: vendor/IT Department steering committees, business/IT weekly meetings, projects kick-off and follow-up, UAT campaigns
 Vendor relationship : interventions planning, administrative management (RFP, quotations, contracts, invoices)
 Project portfolio follow-up and reporting for Project Direction

Integrator on the eFront/ISIS Private Equity solution for CDC/DDTR.
 Coordination (eFront vendor, system/DBMS DPI technical teams)
 Corrective and evolutionary maintenance management
 Management of a transverse Business Intelligence project for CDC-DDTR (BO)