The role can be based in select EMEA 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.
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