eClinical Business Lead

The eClinical Business Lead ensures the technology set-up at a clinical trial’s outset  supports the profitability of the trial, quality delivery, and maximizes the efficiency of operational resources assigned to the trial. For assigned trials, the eClinical Business Lead has global responsibility for the design, requirements gathering and documentation. Also, the accountability for the implementation of technology to meet the specific needs of the assigned trials. The eClinical Business Lead will work with Parexel’s standard technology, and if non-standard technology is required, he/she will escalate to their assigned Client Technology Partner.

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.

Ideal candidate will possess:

• 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.