Lead Clinical Data Manager / Scientist
I am currently recruiting for a global CRO operating in over 80 countries. They are one for the industry leaders striving to be the best at what they do. To achieve this goal it all comes down to employing the best minds and workers out there. If you also strive for the best, this company would be the perfect match for the next step in your career. The role is permanent and candidates can be based In UK or In Europe and will be able to work from home.
Leads end-to-end data review activities performed on a clinical trial. Accountable for achieving clinical data management deliverables on-time, with high quality and to agreed financial metrics. Responsible for applying advanced analytics to centrally aggregate and analyse data from disparate sources to identify risks and issues impacting data integrity, patient safety and/or regulatory compliance. Triages and assigns data review findings to the appropriate project team role for follow-up and resolution. Communicates trending analyses and a summary of findings to internal and external stakeholders to support the on-time delivery of data fit for analysis.
• Serves as the primary contact for internal and external team members regarding clinical data management data review activities and leads these review activities to ensure the delivery of data fit for analysis.
• Provides input into clinical system development activities, to ensure systems support the data review needs of the study, focusing on critical data and processes, and identified risks.
• Ensures clinical data management review requirements are put into production per the study’s protocol risk evaluation and integrated data review plan (IDRP), and that ongoing data review activities are compliant with study plan requirements. Contributes to the development and maintenance of study plans documents specifying data review strategy and applicable procedures on assigned protocols/projects, including but not limited to data management plan.
• Develops and oversees timeliness of clinical data management activities during the life cycle of studies as it relates to data review and data delivery milestones.
• Centrally reviews clinical data at aggregate level, using analytic reporting tool(s) to support the identification of risks and data patterns/trends. Mitigates risks by using signal detection and quality indicators.
• Communicates and triages issues to appropriate roles for follow-up and action to address root cause.
• Proactively identifies out-of-scope clinical data management activities to the study project managers to be implemented in required change orders.
• Leads and hosts the data monitoring meetings, communicating issues to the internal and external stakeholders in a meaningful way such as summarizing the data and representing the information visually
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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