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.
o Excellent verbal and written communication skills.
o Strong customer focus (internal and external)
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
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
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.
o Commitment to quality and quality management.
o Commitment to operational efficiency
o Flexibility to change.
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