A Senior Technical Data Manager with 28 years’ experience working in the Pharmaceutical sector including CROs and Software Vendors. Proven expertise in Clinical trial software (including software and process implementation), data management, process improvement, training and leadership of global programming teams. A respected member of the clinical development team who has the ability to visualise concepts and use new methodologies to provide appropriate solutions to challenges. Management - managing global teams of up to 18 including on-boarding and performance managementClient Relations - worked with external clients in the adoption of new EDC technologies as well as the maintenance of customer relations and expectationsTechnical - expert in data management technologies such as Electronic Data Capture as well as the underlying regulations such as ICH GCP and 21 CFR part 11Training – design and delivery of both formal and more informal on the job training. This covers both software and the underlying processesProcess Management - management of processes from review of SOP’s and working practices to the creation and documentation of new processesCommunication - communicates clearly with all levels within an organisation both technically and non-technically. Experience in delivering formal presentations, including to the DIA conference, Japan in 2010.
Listed skills include Edc, Phase Forward Inform, Clinical Data Management, Library Management, and 28 others.