Hays Pharma
- Study Manager for Bayer Shering Pharma
Paris
2008 - 2011
International project manager / STUDY MANAGER in BAYER SCHERING PHARMA– (59)
Study start up and study execution for an outsourced Oncology Phase III study, breast cancer, International, 560 patients, 23 countries, 100 sites
Study start up and study execution for an Oncology Phase II study, ovarian cancer, International, 240 patients, 14 countries, 70 sites
Study start up and study execution for an outsourced Oncology Phase III study, gastro intestinal tumor, International, 170 patients, 18 countries, 85 sites
Study start up phase for an outsourced Diagnostic Imaging Phase IV study, International, 1000 patients, 11 countries, 80 sites
Study start up phase for a Diagnostic Imaging Phase III study, International, 400 patients, 13 countries, 80 sites
Support for external suppliers management (IVRS, central lab, central reading) for an Oncology Phase III study, lung cancer, International, 900 patients, 20 countries, 90 sites
Key areas of Responsibility:
Management of countries (in Asia Pacific region, in the American region and in Europe)
International conferences
Development of the core study documents including: study protocol, patient information and informed consent, study synopsis, study booklet, eCRF, Study Monitoring Plan, Drug packaging plan, eCRF completion guidelines, newsletters, DMC charter.
Development of the total study budget, for providing monthly/yearly estimates and tracking study budget
Management of operational study feasibility conducted by country and study timelines, milestones, enrollment plan development.
Lead and management of a cross functional Study Team (approx 25 persons)
Study Management and study tracking to ensure ongoing study activities, study execution and timelines (patient enrollment, data cleaning progress and overall study progress).
Training plan strategy development for the study team (monitors, local project manager) and site personnel.
Responsible for planning and conducting investigators meeting (in US, EU and AP region)
For outsourcing strategy or outsourced activities:
o Selection process for the external supplier/CRO (request for proposal, bid defense, kick of meeting) and development of a master signed agreement.
o Definition of the outsourced tasks
o Budget tracking, change orders
o Development of training plan for the external suppliers
o External suppliers / CRO management
o Oversight management
Novo Nordisk
- Local Trial Manager
La Défense Cedex
2006 - 2008
Set up and coordination of a local pediatric phase IV study in type 1 diabetes,of a phase IV study in type 2 diabetes (france, UK).
Set up and coordination of an observational study in growth hormone therapy (pediatrics)and of bservational studies in type 2 diabetes.
Local coordination of an outsourced international phase III study in growth hormone therapy
Key area of responsability :
• Plan, manage and execute study (France, UK)
• External suppliers and budget management (external suppliers selection, contact negociation, kick off meeting, contract agreement and contract amendment)(CRO, central lab, local depot)
• Plan, facilitate and lead study team meetings (teleconference, face to face meeting)
• Create and drive study level timelines
• Review and validation of the site feasibility reports, site initiation reports and monitoring reports
• Develop study level enrolment plan and enrolment projections
• Writing and review of the study documents (protocol, synopsis, inform consent, CRF, patient diary, newsletters)
• Regulatory submissions
• Super user of a clinical trial management software (IMPACT)
• Sponsor Trial Master File
