PharmaCognos
I undertake clinical trial quality management, project and site management and business development on a contract basis. Clients include multinational and local companies and research organizations in Australia, New Zealand and Japan.
Contracts have covered the following areas:
Development of clinical and regulatory development plans
Organisational development (process review and development, process audits, personnel development and project support)
Clinical quality assurance (GCP audits; SOP development, training and implementation; file reviews)
Training (GCP, project management)
Quality management (GCP quality management system development, ISO 9001:2000 implementation)
Scientific and medical writing
Clinical trial project management and operational conduct.