Associate Director - Clinical Systems Quality And Compliance
• Ensure the compliant development, delivery, maintenance and retirement of computerised systems used in clinical trials and wider R&D / Pharma business areas• Develop and deliver appropriate Standard Operating Procedures and Guidelines for use in Computer Systems Validation• Authoring, review and approval of validation deliverables• Conduct Quality Assurance reviews of internal systems• Assessment of external suppliers to establish their suitability for use• Audit of active external suppliers• Advise on the regulatory requirements impacting functionality and data in computerised systemsSince 2009 I have worked on a large number of projects supporting the delivery of clinical trials in AstraZeneca. These have ranged from the simple validation of small applications (e.g. Excel-based systems and bar-code readers) to large-scale, complex and critical systems supporting patient safety activities and the management of Human Biological Samples.This has required the ability to quickly understand customer needs, interpret relevant regulatory requirements, formally assess the risk and determine the extent of validation required for a specific system. It has been important to establish effective working relationships with not only internal customers and IS groups, but also external suppliers, from niche to major global providers, across a range of operating models.At times this has been challenging, as even within the industry there can be inconsistent interpretations of regulatory requirements, leading to conflicting expectations between customer and supplier. Taking a risk-based and pragmatic approach can often lead to an amicable resolution, with the option of formal auditing being pursued where serious concerns cannot be remedied.
