Defining a road map
Prepared a strategy document to outline paths to improve user adoption and speed implementation of computerised clinical trial management system. Covered: release approach, hosting, costing model, database model, services, support, integrations, platform, exporting/reporting and validation.
Working more effectively
Analysis and recommendations for improving communication and team performance in a distributed team.
Maintaining business continuity when using eSource in Early Phase Clinical Trials.
Customer Facing Project Management
Project Manager for the deployment of an eSource/automation system ("EDC") to US and UK based Phase I Units.
Devised and implemented a low impact, low cost eSignature process using off-the-shelf software.
Implemented a low cost, off-the-shelf system to manage the rapid creation, easy editing and online publication of computer system user guides.
Responsible for the internal validation of a major release of a clincal trial management and data capture system for use in 21CFR11 regulated markets.
Project Management System
Deployed a hosted system for the project management of all internal software development and client-facing software implementation projects at EDC provider.
Clinical Trial Audits
Conducted CRO initiated audits of clinical and laboratory facilities/data, and interviews of staff following inspection by regulatory body to provide corrective action recommendations to board of directors.
Quality Management System
Conducted a review and gap analysis of a company's quality system, providing recommendations supporting positioning as a preferred supplier to pharmaceutical companies.
Conducted a review of the management system for company SOPs and other controlled documents and implemented a new system for sharing the published documents with staff.
Quality Management monitoring system
Technology and feasibility assessment of standards-based web platform for risk and compliance monitoring in life science and clinical research business sectors.
Grant Funding Applications
Devised and implemented a system for identifying, targeting and tracking the progress of funding applications.