Associate Director / Director Clinical IT Systems
My Client is looking for a Clinical IT professional from the Life Science sector to oversee a team of approximately 7 IT professionals (Clinical Programmers).
I am recruiting for a technology led European CRO pioneering the way the industry delivers clinical trials in the future. Their decades of pharmaceutical industry knowledge makes them one of the leading experts in the field and are looking for their employees to share the same passion and mind set for the company ethos. This role would suit an adaptable, forward thinking and innovative individual combined with the industry knowledge of clinical trials.
You will be responsible for the development, delivery and on-going management of the CRO’s clinical systems.
You will ensure delivery and development of the CRO System team against key metrics, and work with Senior Managers to develop and grow capabilities, productivity, and quality.
- Leading a team of programmers in the development and implementation of visualizations, BI reports, and reporting integrations.
- Operational leadership, expertise and input to the strategic direction of IT Systems, including Computer System Validation activities and operating procedures.
- Lead CSV activities for systems including client & regulatory audit attendance
- Working with partners globally to ensure high quality and timely delivery of systems & projects aimed at improving quality, reusability, workflow, and efficiency.
- New client/sales work including sales proposals, bid defence meetings, presentations and software demonstrations.
- Manage a global team accountable for the design, maintenance and support of clinical systems and associated processes, including but not limited to:
- Clinical Data Management Systems, including Medidata Rave
- Trial Master File systems (eTMF), including Wingspan and Veeva eTMF
- Clinical Trial Management Systems (CTMS), including Veeva CTMS
- Clinical Reporting systems
- Pharmacovigilance systems
- Contribute to the strategic clinical systems roadmap for the CRO and ensure clinical systems support business processes
- Proactively identify areas which would benefit from new systems and technology by maintaining awareness of industry trends and regulatory changes worldwide in Good Clinical Practice and emerging clinical study and real world evidences approaches.
- Lead delivery of innovative technology to enable clinical studies and analysis while continuously improving operational efficiency
- Develop business cases for new technologies or changes to existing systems which have a clear return on investment
- Ensure adherence to internal and external computer system validation requirements
- Ensure team is collaborating with business process owners and vendors to identify future enhancements to be included in the product roadmap.
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
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