Job Purpose: 

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

Key Accountabilities:

• Serve as the single point of contact with the project team for trial-level technology, and data integration solutions, covering CRS, PI, IT, 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.

Desired experience:

• 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.

• Strong customer focus (internal and external).

• 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.

• Excellent verbal and written communication skills.

• Fluent English.