eClinical Business Lead – multiple EU/UK 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, Parexel Informatics 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 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.
• 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.
• Experience or knowledge of data standards such as CDISC SDTM.
• Strong ability to work to tight deadlines.
• Fluent English.
• Strong customer focus.
• Excellent verbal and written communication skills.
• Good project management skills.
• 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.