Technical referent for Data Management questionsData Managers training and skills developmentStandard operating procedures creation and review

CRF creation and reviewDatabase design, validation and maintenanceQuality checks programming and queries managementQuality controlDatabase reconciliationMedical coding (MedDRA, WHO Drug)ReportingData management documents redaction (Data Management Plan, Data Validation Plan, eCRF specifications, User's guide, EDC Training, Data Transfer Protocol, Data Management Report...)

Part time independentDietary recommandationsNutritional balancing

- Data standardization and annotation of CRF following CDISC- Develop database mapping specifications to produce SDTM datasets from source datasets - Quality Control of deliverables

Overview of the tasks and responsibilities of a Clinical Data Manager including:- Creation, development and validation of Data Management programs (edit-checks, listings...)- Data Cleaning (managing inconsistencies, queries)- Data Coding (MedDRA, WHO Drug)Specific Tools:- SAS (Base/Macro)- SQL- SOPs DATA Management- GCDMP

Overview of the Clinical Study Sector and jobs associated to it.Training course (2 months): theoretical concepts and practical exercises including:- Drug development and clinical research- Clinical development plan, phases (pre-clinical, 1-4)- Pharmacology (PK, PD) and drug metabolism- Quality assurance and quality management: ICH-GCP, GLP, GMP- Regulatory affairs: regulation (FDA, EMA, Belgium), medical product registration, marketing authorization, medical devices, agro-food, post-marketing surveillance (AFMPS)- Medical and scientific writing: clinical protocol, ICF, IB, IMPD, report, regulatory documents- Publication management- CRA: site identification, selection, initiation, monitoring and closure visits- Clinical project management- Data management: CRF design and functionality, database design, data encoding and validation- Biostatistics: statistical analysis, statistics in preclinical studies, designs of clinical trials, sample size calculation, randomization- Communication and negotiation skills

Techniques of microbiology, Bacteriology, Cell Culture (thawing, passaging, counting)Molecular biology (Plasmid dna purification, Enzymatic restriction, Agarose gel electrophoresis, Bacterial transformation, Recombinant protein production and purification (AKTA Prime), SDS-PAGE analysis, HPLC)PCR, indirect ELISA

OTC division from EurogenericsContact with general and specialist practitioners, pharmacistsTargeting customers needsPlanning management

Outsourcing Neocare : jan - june 13Syndicated Team Quintiles (Pfizer and Norgine) : sept - nov 12Pharmaceutical products presentation and promotion

Patients reception, orientation and supportDietary assessment, guidance and follow upPre and post operation food adviceInterdisciplinary team meetingCreation and database management