Mes compétences :
Gestion de projet
Management
R&D
Entreprises
Novartis
- Clinical Trial Budget Manager - Oncology Global Development
RUEIL MALMAISON 2016 - maintenantResponsible for the budget management of 2 clinical programs:
- Over 20 Global clinical studies with study lifetime budgets ranging from $750k to $65m (total portfolio budget $210m)
- Manage financial requirements of clinical program budget by providing consolidated latest estimates on current year budget and future year planning budget.
- Identify issues and propose mitigating plans for facilitating decision making.
- Challenge and track program/trial timelines, resource requirements and expenditures and initiate adjustments as needed.
- Ensure clinical trial planning and budgeting systems are accurate regarding timelines, forecasts, expenditures and internal resource planning.
- Ensure budgets remain in line with internal benchmarks and historical spending data.
- Provide clinical trial process and budget training to clinical staff.
BIO-RAD
- Project Manager (PMO)
Marnes La Coquette2010 - maintenantManagement of Multi-projects (portfolio of up to 8 projects) in the medical diagnostic area.
· Large scale of project types: regulatory implementation (accreditation, labeling), defining and
implementation of the new division strategy, manufacturing transfer, registration process (CE mark,
Health Canada, FDA) and new product development projects.
· Managing US clinical evaluations (FDA) and 510k submissions/clearance through internal or
external partners (clinical budget 200k$ - 800k$).
· Coordination of cross-functional teams: R&D, marketing, manufacturing, regulatory and clinical
affairs, quality assurance, patent, legal partners in France, Europe and US.
· Monitoring of project scope, delay and cost to ensure project completion on schedule using MS
project. Set up regular projects review meetings with core teams, stakeholders and/or external
partners.
· Collect deliverables and implement the project design history files, risk identification and definition of
mitigation plans.
· Ensure compliance to quality system, regulatory procedures, and design controls. Good
knowledge of FDA 21CFR & GMP, ISO 13485 / 14971 / 15189 / 21500 and CLSI recommendations
under strong regulation and legal constraints (FCPA, sunshine Act …).
Bio-Rad
- R&D project manager
Marnes La Coquette2007 - 2010Significant success for developing and launching a new HIV Combo diagnostic kit, qualitative
immune-assay for the combined detection of HIV Ag and Ab anti-HIV to run on multi-automations
(Access, Beckman Coulter).
· Management of four technicians and one project leader assistant.
· Coordination of the project, planning monitoring to meet deadlines
· Cross-functional collaboration with patent, legal, transfer platform and quality department
(regulatory and clinical), Hospitals and Blood Banks.
· Scientific survey: bibliography and congress attendance.
Bio-Rad
- R&D project manager assistant
Marnes La Coquette2004 - 2006Development of new innovative diagnostic tools (ELISA) for cardiac diseases.
· Multi-analyte study to help the stratification of cardiovascular diseases: Identification and validation
of new biomarkers after development of ELISA testing.
· Clinical study protocol redaction with ethic comity validation and monitoring of the serum bank.
Collaborations University Hospital of Nîmes (Dr Bertinchant, 2004-2005).
Veterian Hospital of San Diego (Nov. 2006)
