Amsterdam Area, Netherlands
CCA/eTMF Manager at GSK Vaccines
Information Services
Education
University of Northumbria At Newcastle 2001 — 2003
MSc with Commendation, Records Management
University of York 1986 — 1989
BSc(Hons), Biology
Experience
GSK March 2015 - Present
Novartis Vaccines and Diagnostics December 2011 - February 2015
Genzyme Europe September 2003 - November 2011
Railtrack October 1995 - February 2003
Interlogic (formerly British Rail DoSTE) July 1989 - February 1995
Skills
Inspection Readiness, Management, ICH-GCP, Cross-functional Team..., Quality Control, FDA, Clinical Data Management, EDC, Inspection, Validation, Project Management, Lifesciences, Clinical Trials, Drug Development, Change Control, Software Documentation, Sop, Document Management, Pharmacovigilance, Biotechnology, Data Management, Medical Devices, CAPA, CRO, Regulatory Affairs, Quality System, Clinical Monitoring, Records Management, GxP, Livelink, Clinical Operations, GMP, Pharmaceutical Industry, Computer System..., GCP, Training, Medical Writing, Documentum, Therapeutic Areas, Regulatory Requirements, Biopharmaceuticals, Oncology, Quality Assurance, Vaccines, Clinical Development, 21 CFR Part 11, Regulatory Submissions, Regulatory Operations, CTMS, GLP