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eClinical Business Lead - Poland, Romania, Italy, Spain, Hungary, Lithuania

职位编号 R0000009517 工作地点 西班牙 职位描述

The role can be based in multiple European locations - Poland, Romania, Italy, Spain, Hungary, Lithuania

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.