eClinical Business Lead - based in the UK/South Africa or selected EU locations
Primary Location: United Kingdom, Remote Additional Locations: Poland, Remote; Romania, Remote; South Africa, Remote; Spain, Remote ID de la oferta R0000036452 Categoría Administrativesobre este trabajo
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
Lead the implementation of the eClinical platform for a study
Serve as the primary point of contact internally and with external customers as needed regarding study technology, data integrations, and requirements
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)
Analyze protocols and collaborate with all stakeholders to create and review user requirements and integration needs
Identify and mitigate any risks related to system set-up and integrations with internal systems and/or sponsor systems
Focus on timely, high-quality delivery of all services provided
Stay current on the latest Parexel technology offerings, integration issues, and relevant clinical trial process developments in the industry
Client Management
Interact with external clients as needed for discussion on technology set-up, modifications, and integrations
Demonstrate a proactive approach to providing solutions in a timely manner
Here are a few requirements specific to this advertised role:
Proven experience in clinical trials (CRO/Pharma).
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.
Experience in clinical trial systems (e.g., CTMS, EDMS, EDC, IVRS, reporting tools) and in configuration of these systems.
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.
Experience or knowledge of data standards such as CDISC SDTM.
Strong ability to work to tight deadlines.
Fluent English.
Strong customer focus.
Excellent verbal and written communication skills.
Good project management skills.
In depth understanding and experience of clinical trial processes.
Proven ability to manage independently competing priorities with attention to detail.
Demonstrated adeptness in learning new systems and function in an evolving technical environment.
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