e-Clinical Business Lead - select UK/EU locations

United Kingdom-Uxbridge-Remote United Kingdom, Remote Job ID R0000030238 Category Administrative ABOUT THIS ROLE The role can be based in select European locations Picture Yourself At Parexel: The role leads the implementation of technology at a clinical trial’s outset, ensuring timely start-up, quality delivery, and compliance with the study protocol and client contracted services. The individual has responsibility for the design, requirements gathering, requirements documentation, and configuration. What You'll Do At Parexel: • Serve as the single point of contact with the project team for trial-level technology, and data integration solutions, covering Clinical Research Services, and technology third party vendors. • Define and document requirements for the trial technology. • Be accountable for all technology set-up for assigned trials; this includes working with colleagues across departments who have specific responsibilities for part of the set-up. • Coordinate the teams responsible for delivery of the technology for a trial, including design, using standard components, based on customer requirements, planning and coordination of delivery of the technology and input to the overall project plan. • Ensure the quality, timeline and budget related to the trial technology meets the project requirements. • Escalate requests or requirements for non-standard technology to the assigned Client Technology Partner. • Set-up trial technologies if appropriate. • Ensure project team satisfaction of the trial technology solution. • Train and mentor junior eClinical Business Analysts. • Stay updated on technology and clinical trial process developments and requirements within Parexel. Ideal candidate will possess: • Proven experience in clinical trials. • Global virtual team coordination experience for trial technology set-up. • Ability to develop detailed awareness of Clinical Research Services, external vendor software and tools with practical knowledge of how these applications work and provide efficiency to operations. • Experience in clinical trial systems (e.g., CTMS, EDMS, EDC, IVRS, reporting tools) and in configuration of these systems. • Good project management skills. • Excellent verbal and written communication skills. • Fluent English. • Strong customer focus. • Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. • Awareness/experience in the needs and use of data standards in clinical trial environment; if possible, knowledge of data standards such as CDISC SDTM. • In depth understanding and experience of clinical trial processes. • Proven ability to manage independently competing priorities with attention to detail. • Demonstrated adeptness in learning new systems and function in an evolving technical environment. #LI-REMOTE