BrightOwl Loader Loading

Summary

central point of contact for processes within global data solutions & strategies (gdss) as related to quality and compliance. collaborate with Regulatory Compliance and quality Operations teams in regards to audits and inspections.

liaise with external industry forums. assess compliance to regulatory agency policies and provide guidance within gdss. engage and contribute to SOP development for business unit amongst the many other quality related responsibilities.

Experiences

Current Experience

  • Compliance Lead, eClinical Operations


    Since August 2015
    central point of contact for processes within global data solutions & strategies (gdss) as related to quality and compliance. collaborate with Regulatory Compliance and quality Operations teams in regards to audits and inspections. liaise with external industry forums. assess compliance to regulatory agency policies and provide guidance within gdss. engage and contribute to SOP development for business unit amongst the many other quality related responsibilities. Central point of contact for processes within Global Data Solutions & Strategies (GDSS) as related to quality and compliance. Collaborate with Regulatory Compliance and Quality Operations teams in regards to audits and inspections. Liaise with external industry forums. Assess compliance to regulatory agency policies and provide guidance within GDSS. Engage and contribute to SOP development for business unit amongst the many other quality related responsibilities.

Past Experience

  • sr. Protocol Data Manager

    December 2005 --- July 2015
    bristol myers squibb int., Research & development (data Operations, braine l’alleud). specify, maintain and supervise Data Management activities. Therapeutic Areas: hcv, protease inhibitors (hiv), selective costimulation t-Cell inhibitors, human Monoclonal Antibodies (Immunology, immuno-oncology, auto-immune diseases, colorectal Cancer, melanoma), dopamine serotonine stabilizers (CNS). . •extensive, data metric-driven, Project Management of distributed (bms hub, CRO) data and site associates and monitors. portfolio of global studies: americas, w. and ceet, pacific rim (india, china, australia) •continuous process improvement - CRO Quality Management •jreview eu sme (SAS and SQL imports) •eclinical forum/ehrcr working group Member •scdm, incdma Member. •electronic Health records for Clinical rsearch working group.

  • Clinical & Statistical Programmer-Analyst

    April 1998 --- December 2005
    Statistical report generation -data review and submission activities •create or validate metadata definitions and data collection systems, crfs, acrfs (oracle, SAS annotations). create or validate mapping, data warehousing and Data Mining systems and processes meeting specifications of a large variety of sponsors (gov, biotech, pharma) and regulatory environments (us, eu, uk, cet, australia, japan, taiwan, s. korea). •create or validate electronic edit checks and data review listings and reports •integrated review Trainer and sme. •participating in core multidisciplinary Clinical team decisions, science)" rel="nofollow">Protocol and Statistical Analysis design, data Validation manuals, sample selection, blinding and un-blinding, enrolment and recruitment, study Strategy, post lock activities, response and management of data aspects during internal and external audits. •acting Project Manager for standalone programming assignments •Data Management setup, study conduct and lock activities for >20 Clinical studies (Phase I-iv, tas: Immunology, oncology, Infectious diseases, Neurology, Endocrinology …)

Knowledge

LinkedIn Assessment :
Clinical trialsClinical Data ManagementCROGCPEDConcologyData ManagementClinical DevelopmentICH-GCPProtocolCTMS21 CFR Part 11NeurologyImmunologyPharmaceutical IndustrySASBiotechnologyInfectious diseasesOracle ClinicalClinical researchTherapeutic AreasPharmacovigilanceDrug DevelopmentSOPCDISCRegulatory submissionsSOPStandard Operating Procedure (SOP)U.S. Title 21 CFR Part 11 RegulationCRO management

Education

  • Bachelor of Business Administration (BBA) in Business, Management, Marketing, and Related Support Services from Athens University of Economics and Business in 1997
  • Undergraduate in Health Visitor / Preventive Medicine & Epidemiology Nursing from National Technical University of Athens in 1990

Area / Region

Havré, Mons, Belgium

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Belgium

Other Candidates in Mons

Other similar Candidates in Mons

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like