Cegedim Strategic Data
- Medical and Scientific Director
2011 - 2013
Management
Management of a staff of up to 40 permanent employees, consultants and fixed-term contract employees.
Business development
Scientific and medical support for CSD’s business developers.
Review of proposals and participation in bid defence meetings.
Implementation of the QA system
Validation the data management software (INES) according to the GAMP5 guidelines.
Updating of Data management, statistical analysis and medical writing procedures
Implementation of the process of data validation for CSD’s LPD (EMR).
Methodology and Statistics
Standardization of the statistical analyses process over all CSD’s subsidiaries. Development of a standard library of macros.
Implementation of new statistical methods for observational studies: propensity score matching and adjustment, handling of missing data by multiple imputations, Markov chain analysis for analysis of treatment pathways, multivariate logistic regression, Cox models, ...
Medical and scientific support
Review of all documents from the Medical Research team (protocols, final reports, abstract, publications, ...)
Organization of medical and methodology training sessions;
Member of the task force working on LPD.
CKConsulting
- Consultant
2009 - maintenant
Founder of CKConsulting
- Medical, Scientific and Operational expertise (interventional and non interventional studies)
- Consulting in biometry, methodology, statistics, SAS programming.
- Medical writing: Protocol, CRF, Statistical Analysis Plan, Statisitcal Report, Final Study Report, Posters, Scientific Paper
Integrated Clinical Data
- General Manager
Scottsdale
1993 - 2009
Founder general manager (1 000 K€, 15 people).
Medical and operations director.
Creation of ICD, a CRO specialised in clinical trials and epidemiological studies data management and processing.
Management
Self-employed manager of ICD.
Business development : up to 1 000 000 € annual turnover.
Management of a staff of up to 15 permanent employees, consultants and fixed-term contract employees.
In charge of the company in total autonomy, with definition of the business strategy and conduct for all functional aspects.
Implementation of the QA system
Writting and implementation of SOPs covering all operational aspects of the business: IT system, data back-ups, clinical trials monitoring, data management, statistical analysis, medical writting.
Validation the data management software according to the GAMP4 guidelines.
Validation of the SAS software intallation as well as of the SAS macro library.
Data management
Design and development of a 21-CFR part 11 Access for Windows based data management software (e-CD).
Design and development of PDA and smart-phone based patient diaries (e-diaries).
Design and development of a web-based interface for the e-CD software (e-CRF). Design and development of the corresponding web-based administration tools.
Implementation of the coding dictionaries and procedures (WHO-DD, MedDRA).
Data management of more than 100 phase I to IV studies in various therapeutic fields: oncology, cardiology, CNS, infectious diseases, nutrition, rheumatology, endocrinology and metabolism, dermatology, medical devices.
GAMP 4 validation of the data management system.
Statistics
Development and validation of a SAS macros library for tabulation of the results, non-inferiority analyses, survival analyses, confidence intervals, …
Statistical analysis of the results of more than 100 phase I to IV studies in various therapeutic fields oncology, cardiology, CNS, infectious diseases, nutrition, rheumatology, endocrinology and metabolism, dermatology, medical devices.
Medical writing
Member of the American Medical Writer Association (AMWA) for 9 years. Training courses: writing of clinical study reports, writing of articles, making effective slides, …
Development of WORD models compliant with the ICH E3 guidelines.
Writing of articles, clinical study reports, CTD part 2.5 and 2.7, investigators’ brochures, bibliographical revue in various therapeutic fields: oncology, cardiology, CNS, infectious diseases, nutrition, rheumatology, endocrinology and metabolism, dermatology, medical devices.
