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eClinical Business Lead, UAT Lead

4 months ago

REMOTE, United Kingdom Parexel Full time

The role can be flexibly based in the UK, South Africa, Poland, Romania, Lithuania

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 oversight cand delivery of User Acceptance Testing of clinical systems and associated documentation.

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 General Administration Maintain a positive, results oriented work environment, modeling teamwork, and communicating with team members in an open, balanced, and objective manner Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices Complete routine administrative tasks in a timely manner (e.g., timesheets, training) and in compliance with relevant guidelines Ideal candidate will possess: Several years of life science industry experience (CRO/Pharma) Experience in eclinical software testing Experience in IRT/RTSM and/or Digital Health Technology system delivery Ability to manage independently competing priorities with attention to detail Ability to learn new systems and function in an evolving technical environment Global virtual team coordination experience for trial technology set-up Excellent verbal and written communication skills Ability to work to timelines Fluent English Strong customer focus 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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