Offer summary

Qualifications:

Proven experience in clinical trial systems such as eCOA, ePRO, and IRT., Bachelor’s degree as a minimum requirement., Knowledge of Good Documentation Practice and ICH-GCP regulations., Excellent verbal and written communication skills in English..

Key responsabilities:

Oversee and manage User Acceptance Testing (UAT) of eClinical vendor systems.

Create project plans for UAT deliverables and manage timelines.

Serve as the main point of contact for UAT with project teams and vendors.

Train and mentor junior team members while ensuring project satisfaction.

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The role can be based in South Africa, UK or select European locations

Picture Yourself At Parexel:

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.

What You'll Do At Parexel:

Oversee and manage the delivery of User Acceptance Testing (UAT) of Eclinical vendor systems including, IRT, eCOA, ePRO and integrations.
Create project plans for UAT deliverables. Manage and negotiate timelines and be accountable for on time delivery.
Serve as the main point of contact for UAT with the project team, vendor, and sponsor.
Develop and maintain excellent customer relationships.
Interpret clinical protocols and highly technical user requirements documentation.
Identify and create suitable test case scenarios and prepare test scripts based on user requirement specifications to ensure software functionality is appropriate tested.
Ensure your work is captured correctly in the project budget.
Ensure the quality, timeline and budget related to the trial technology meets the project requirements.
Identify and Escalate requests or requirements for non-standard technology to the appropriate contacts.
Ensure project team satisfaction of the trial technology solution.
Train and mentor junior members of the team.
Stay updated on clinical systems technology best practices, clinical trial process developments and requirements within Parexel.

Who we’re looking for:

Proven experience in clinical trial systems (e.g., eCOA, ePRO, IRT, Integrations) and in configuration of these systems is a must have.
Prior experience in identifying test case scenarios.
Knowledge or experience of Good Documentation Practice in electronic testing.
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.
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.
Proven ability to independently manage competing priorities with attention to detail.
Excellent verbal and written communication skills.
Fluent English.
Bachelor’s degree as a minimum.
Demonstrated adeptness in learning new systems and function in an evolving technical environment.

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program. We offer competitive financial packages, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Parexel has a fully flexible work arrangement - you can be fully home based. But if you live close to our office and you want to use it, you are always welcome, and we will keep the desk ready for you!

We are unable to sponsor or take over sponsorship of an employment Visa.

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