Clinical System Set-up Analyst (Poland, Romania, Italy, Spain, Hungary, Lithuania)

Parexel International Corporation

Multiple Locations

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

The Clinical System Set-Up Analyst ensures the technology set-up at a clinical trial’s outset supports the profitability of the trial, ensures quality delivery, and maximizes the efficiency of operational resources assigned to the trial.

For assigned trials, the SSA has global responsibility for the design, requirements gathering, requirements documentation, and the accountability for the implementation of technology to meet the specific needs of the assigned trials. The SSA will work with Parexel’s standard technology, and if non-standard

technology is required, the SSA 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 more junior System Support Analysts

Stay updated on technology and clinical trial process developments and requirements within Parexel

Ideal candidate will possess:

Excellent verbal and written communication skills

Strong customer focus (internal and external)

Coordinating global virtual teams around trial technology set-up

Ability to motivate and work effectively with virtual teams within different cultural environments

Experience in clinical trial systems (e.g, CTMS, EDMS, EDC, IVRS, reporting tools) and in configuration of these systemsProven ability to manage independently competing priorities with attention to detail

In depth understanding and experience of clinical trial processes

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

Good project management skills

Technical and data standard experience

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

Demonstrated adeptness in learning new systems and function in an evolving technical environment

Awareness/experience in the needs and use of data standards in clinical trial environment; if possible knowledge/experience of data standards such as CDISC SDTM

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2023-01-14 00:05:17

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