Over the past 30+ years Jane has moved from routine data cleaning activities, via system validation on to training and data quality activities, eventually specializing, within her role as a Quality Risk Manager, in Risk Assessment and Management. Jane's Risk Assessment and Management expertise covered a range of areas from the R&D Management team, through individual departments and then clinical trial teams and process improvement projects, not forgetting software development projects, large and small. Over that period of time Jane has worked for a number of major Pharmaceutical companies and CROs, before retiring from one of the top pharmaceutical companies.
Jane has also been involved as a contributory author to a number of System Validation guidelines â?? Computer Systems Validation, A Practical Guide 1998; Computerized Systems Validation in Clinical Research, A practical guide 2004 and most recently Validation and Management of e-Clinical Systems in Collaborative Clinical Trials 2015.
Jane now operates as a Risk Management Trainer and consultant, specializing in Study Level Risk Management and Risk-based Monitoring as well as facilitation of risk assessment workshops.