eClinical Business Lead - based in the UK/South Africa or selected EU locations

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 fully home based in selected European locations or South Africa
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 :
Project Delivery

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Lead the implementation of the eClinical platform for a study

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Serve as the primary point of contact internally and with external customers as needed regarding study technology, data integrations, and requirements

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Collaborate with Project Leaders, Project Specialists, and other study team members on study technology needs from the point of early trial planning through trial execution if needs change (e.g., under a protocol amendment)

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Analyze protocols and collaborate with all stakeholders to create and review user requirements and integration needs

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Identify and mitigate any risks related to system set-up and integrations with internal systems and/or sponsor systems

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Focus on timely, high-quality delivery of all services provided

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Stay current on the latest Parexel technology offerings, integration issues, and relevant clinical trial process developments in the industry

Client Management

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Interact with external clients as needed for discussion on technology set-up, modifications, and integrations

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Demonstrate a proactive approach to providing solutions in a timely manner

Here are a few requirements specific to this advertised role:

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Proven experience in clinical trials (CRO/Pharma).

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Global virtual team coordination experience for trial technology set-up.

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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.

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

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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.

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Experience or knowledge of data standards such as CDISC SDTM.

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Strong ability to work to tight deadlines.

- Fluent English.

- Strong customer focus.

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Excellent verbal and written communication skills.

- Good project management skills.

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In depth understanding and experience of clinical trial processes.

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

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

Originally posted on Himalayas