BONJOUR,

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MERCI BEAUCOUP!

Clinical Data Manager/ Programmer
PROFILE
Clinical Data Management professional with experience managing CDM responsibilities within Oracle Clinical, Inform, Clintrial and SAS Systems, developing/maintaining global data standards, CDISC/STDM mapping, validation/edit check programming, ad hoc reporting, editing/querying clinical data for consistency and accuracy, medical coding, management of clinical studies from data-base set-up to data-base lock ,developing/maintaining internal documentation, specifications and processes. Create/deliver departmental training and ongoing mentoring. Involvement in validation and quality control of new/updated application systems
Career Objective: To obtain an international position in Clinical Data Management using my French and English skills to bridge gap between the two cultures.

Technical Experience
Programming knowledge and familiarity in SQL, PL/SQL, SAS
ecrf sofware : ORACLE Clinical V4.03/ V4.5, INFORM, CLINTRIAL 4.03
Software: ACCESS, ENTRY POINT, SYMETRYC, DATA WAREHOUSE
Proficient in Microsoft Windows; Microsoft Office
Extensive working knowledge of CDISC/SDTM standards


PROFESSIONAL EXPERIENCE
2001 - Present
xxxxx Company (Lxxxxx, France), Contractor in clinical research activities.
I worked at the following companies via this Contract Research Organization:

Since January 2010 
xxxxx Company (Uxxxxx, France) as Business Administrator under SAS Data Warehouse and Inform (ecrf)
• Administrate Ipsen standard data model in consistency with drug development operational objective and timelines
• Ensure clinical studies are compliant with the standard (standard (e) CRF pages/forms, external data process)
• Develop/maintain global data standards, CDISC/STDM
• Take part in the solution of problems send to Data warehouse group
• Create/deliver departmental training and ongoing mentoring
• validation and quality control of new/updated application systems
• Create and maintain the documentation: user guide, guideline, database structure specification, CRF completion guideline...
• Review the study protocols and the draft of (e)CRF/CRF
• Review and validate the study database specification
• Perform the testing/UAT for (e)CRF screens, database structure, data loading, etc…

April 2001-december 2009
xxxxx company (Cxxxxx, France)

Study database support group, April 2007 – December 2009
as Database Designer under Clintrial V4 and ORACLE Clinical (RDC)
• Design databases for clinical studies (setup).
• Edit Check Programming according to “Data Validation Plans” for several studies
• Ensure clinical studies are compliant with the standard (standard (e) CRF pages/forms, external data process)
• Take part in the solution of problems send to Database group
• validation and quality control of new/updated application systems
• Perform the testing/UAT for (e)CRF screens, database structure, data loading, etc…


as Clinical Data manager under Clintrial V4 and SAS
July 2006 – January 2004; Oncology area :
• Management of clinical studies from data-base set-up to data-base lock within Clintrial V4.3
• Consistency check and CRF data-quality: clinical data validation, queries management.
• Meetings preparation and organization: data-review, pre-lock meeting, clinical trial team meeting.
• Study documents preparation and update: follow-up with CRF design, preparation of CRF completion guidelines, data entry conventions, data-transfer specification, data-validation plan and data-review plan, Monitoring Plan and Data Management Plan

July 2003 – January 2004; Phase I:
• Management of clinical studies from data-base set-up to data-base lock within Clintrial V4.3
• Consistency check and CRF data-quality: clinical data validation, queries management.
• Meetings preparation and organization: data-review, pre-lock meeting, clinic