Job Description

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.

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

Qualifications

Communication

Excellent verbal and written communication skills

Strong customer focus (internal and external)

Coordinating global virtual teams around trial technology set-up

Proven ability to manage independently competing priorities with attention to detail

Experience in team coordination and requirements gathering

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

Ability to negotiate and influence in order to achieve results

Technical and data standard experience

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

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

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

Business process

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.

General

Commitment to quality and quality management.

Commitment to operational efficiency

Flexibility to change.

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.