System Set-up Analyst

Essential Function

The System Set-Up Analyst (SSA) 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.

This role requires understanding the detailed needs of the study, the technical capabilities of Parexel’s technology, and the way our Operational groups can maximize efficiency using these tools. The SSA will keep current on the latest developments and technology options through training and mentorship opportunities provided by the Client Technology Partners and other resources, both inside and outside the organization.

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 ParexelQualificationsMinimum Work Experience

• Substantial experience in the Clinical Trial business, understanding the process steps and contributors involved

• Proven record of influencing a team to deliver according to a schedule

• Experience of configuring technology for Clinical Trials (Systems Development Experience not required)

• Experience in EDC, eSource system, eCOA requirements or design is a plus

Skills

• Communication

o Excellent verbal and written communication skills.

o Strong customer focus (internal and external)

• Coordinating global virtual teams around trial technology set-up

o Proven ability to manage independently competing priorities with attention to detail

o Experience in team coordination and requirements gathering

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

o Ability to negotiate and influence in order to achieve results

• Technical and data standard experience

o Experience in clinical trial systems (e.g, CTMS, EDMS, EDC, IVRS, reporting tools) and in configuration of these systems

o Develop detailed awareness of CRS, PI and external vendor software and tools with practical knowledge of how these applications work, and provide efficiency to operations

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

• Business process

o In depth understanding and experience of clinical trial processes

o 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.

• General

o Commitment to quality and quality management.

o Commitment to operational efficiency

o Flexibility to change.

Education

• Education in life sciences and/or computer sciences and / or equivalent experience.

Language Skills

• Excellent English written and oral communication skills.