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 AfricaPicture 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 DeliveryLead the implementation of the eClinical platform for a studyServe as the primary point of contact internally and with external customers as needed regarding study technology, data integrations, and requirementsCollaborate 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 needsIdentify and mitigate any risks related to system set-up and integrations with internal systems and/or sponsor systemsFocus on timely, high-quality delivery of all services providedStay current on the latest Parexel technology offerings, integration issues, and relevant clinical trial process developments in the industryClient ManagementInteract with external clients as needed for discussion on technology set-up, modifications, and integrationsDemonstrate a proactive approach to providing solutions in a timely mannerHere 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.Originally posted on Himalayas