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Catégorie :

Consulting

Date de dernière mise à jour :

28 avril 2010

Lieu :

amerique du nord

CV :

Farida Dabouz, Ph.D.
FB2D Clinical Research Consulting Inc.
Montréal, (Québec – Canada)
Cellular: 514 892-6451, Fax: 514-685-0621
E-mail: FB2DClinicalResearch@sympatico.ca
WWW.FB2DCONSULTING.COM


CAREER PROFILE

Senior Director, bilingual, with over 21 years experience in management, ensuring clinical data integrity and quality, business development technologies, implementation of technology solutions in the pharmaceutical research and quality assurance. Fourteen years experience in managing clinical projects, co-monitoring, validating data and systems, coding using MedDRA, Costart/Whoart and WhoDrug dictionaries, analyzing and writing study reports mainly in oncology (Breast, Prostate and Hematology Cancer), cardiovascular, rheumatology (OA) and gastroenterology (GI) clinical research. Basic knowledge in pharmacogenomics.

PROFESSIONNAL EXPERIENCES

Consulting services – Broaden and Multidisciplinary Expertise Mar 04 – now

 Project Management,
 Medical writing (Protocols, Clinical Study Reports, Investigator Brochures, Articles),
 Data Management (Data Validations Guidelines, System Validation, CFR Part11, eCRF),
 Statistics (SAP, Statistical Analyses, Statistical Reports),
 Standard Operating Procedures’ (SOPs) Writing,
 Training (ICH-E6 (GCP), E8, E3, E9, E10; SOPs),
 Audit (Sites, CROs).

Galileo Genomics Inc., Montreal July 03 – Feb 04

Director of Data Management

Implementation of one study into the new Clinical data management system (eRT software). Lead the project and provide expertise to the project team. Define the new workflow processes and develop SOPs as per 21 CRF Part 11 requirements. Improve the actual data management processes using the in-house software.

Integrated Research Inc., Montreal Sep 02 - July 03

Head of Data Management and Statistics

Responsible for Data management tasks and processes within clinical trials. Set-up Statistics department. Develop SOPs
Protocol and Clinical study reports writing. Perform in-house CRAs training.

Bioniche Life Sciences, Montreal Jan 02 - Sep 02

Manager, Clinical Technology/Product manager

Responsible for developing and implementing technology within clinical development. Provide data management and statistics advice to clinical team. Liaise with CRO.
Responsible for Osteoarthritis product.


P\ S\ L Research Group, Montreal Aug01- Jan 02

Chief Statistician, consulting

Responsible for training P\S\L research team on statistical methodology for marketing research and developing/implementing new technical/statistical strategies within P\S\L.

Breast Cancer International Research Group (BCIRG) 1997- 2001

Director of Technology Development, BCIRG Montreal 1999- 2001

Project manager for evaluating new technology solutions for clinical trials and validating/implementing technical strategies within BCIRG.

Accomplishments:
 Developed recommendations for new technology solutions
 Submitted to the Chairman of BCIRG the implementation plan of new technology solutions
 Managed validation/implementation of Project Management software within clinical operations
 Managed development, validation and implementation of Electronic Data Capture system
 Coordinated successfully an Internet based randomization process
 Developed validation methodology
 Ensured technology compliance with FDA Guidelines (21CFRpart11,)
 Developed data management SOPs pertinent to management of e-records and system validation.
 Presented implementation of EDC at meeting

Head of Data Management Department, BCIRG Edmonton 1997-1999

Participated in company start-up. Managed a team of 10 employees and responsible for the clinical data processing, data management budgets, software licensing, preparation of management reports, SOPs, reviews and update of data management systems. Participate in reviewing protocols, designing CRF, writing statistical analysis plans.

Accomplishments:
 Built data management department: developed a strategic plan, evaluated timelines, and assessed resources, tools and budgets.
 Performed data management tasks: set-up, evaluated and approved databases, developed SOPs, validation tools and data output according to company guidelines and standards
 Managed and trained two statistician trainees
 Managed a team of Data managers, Data coordinators, Data entry, Database administrator and SAS programmer
 Provided training for CRAs on data monitoring and data validation processes
 Provided global clinical support systems (21CFRpart11)
 Developed SAS application for cleaning/validating clinical data
 Developed Oracle application for auto encoding Adverse Experiences/Concomitant medications
 Presented a poster at PHARMASUG (New Orleans): BCIRG SAS system for data validation



Rhône Poulenc Rorer (RPR) 1992-1997

Head of Data Management / Statistician, RPR Montreal 1996-1997

Responsible for implementing the data management activities within the RPR Canadian affiliate. The RPR headquarter reengineered the clinical trials processes and the Canadian affiliate played a key role in the decentralization of data management tasks.

Accomplishments:
 Performed data management tasks: database set-up, validation tools, data validation and coding
 Performed statistical analysis of Canadian clinical trials
 Maintained contact with RPR headquarter
 Participated in generating posters and was published in certain publications
 Co-monitored with CRAs (Europe and Canada) to improve data quality
 Managed pharmacy department in parallel with Data Management department

Senior Statistician / Senior Data Manager, Chugai Rhone Poulenc Paris 1992-1995

Manage a team of six employees and responsible for transferring data management activities from CRO to Chugai RPR.

Accomplishments:
 Performed statistical analysis plan, statistical analysis and reports of clinical trials in area of oncology
 Responsible for data management team: database set-up, validation tools, validation data and coding
 Prepared posters with marketing department for oncology convention
 Prepared statistical results which were published in trade magazines
 Prepared Dossier for submission to European agencies
 Managed and trained junior data manager and junior statistician
 Co-monitored with CRAs Phase I studies in Sweden


Synthélabo Recherche (LERS), Paris 1988 - 1992

Statistician

Responsible for analyzing clinical data and preparing statistical reports.

Accomplishments:
 Performed statistical analysis of clinical trials in cardiology and CNS areas
 Generated consistency checks by using CLINTRIAL
 Co-ordinate with data managers the standardization of clinical databases
 Prepared Dossier in cardiology for submission to European agencies
 Worked with a user group on documenting a SAS survival procedure which was presented in a SAS user group meeting.




OTHER EXPERIENCES

Training: GCP and Statistics in Clinical Research May 2005 to 2009
University of Montreal

Training : Bonnes Pratiques Cliniques, Comment écrire un protocole de recherche Jan – April 2008
Hôpital Sacré-Cœur de Montréal

Training: CRF électronique : Avantages et inconvénients – Promoteur vs. Investigateur Dec 2007
Démystification des Statistiques en Recherche Clinique May 2007
AQIIR

Professor of Mathematics and Statistics 1980-1981
University of Algiers

Trainee as Statistician 1985-1986
Électricité De France (EDF), Paris

Professor of Mathematics and Statistics 1984-1988
High schools, Paris

FORMAL EDUCATION

Master’s degree in Probability/Statistics 1980
University of Algiers

Ph.D. in Statistics 1984
University of ParisVI

Statistician Diploma 1986
Institut de Statistiques de l’Université de Paris

Training
Oncology: RPR, BCIRG, convention/seminar, Bioniche
GCP: BCIRG, Integrated Research, MHICC
21 CFR Part11 (ISPE)
COMPUTER KNOWLEDGE

Operating System: Windows NT,
Software: eRT products, Clintrial,
SAS (Base, Stat, AF, FSP, and Graphic), SPSS,
MS Office 95/97/98/00, XP MS Project,
Visio, nQuery, PowerandPrecision,
Data base: Oracle.

PROFESSIONAL AFFILIATIONS

• AQRC, AQIIR, Chambre de Commerce de Montréal

Remarques :

Avec une expertise diversifiee et une tres bonne connaissance de la reglememtation (EMEA, FDA,Sante Canada, certains pays arabes) et les directives ICH , les services offerts couvrent toutes les etapes d'un essai clinique, incluant la formation et l'audit. Les services peuvent etre offert en anglais ou en francais.
Au plaisir de repondre avec qualite a vos besoins.
Best regards/Sincerement
Farida Dabouz

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