eClinical Business Lead, UAT Lead - select EMEA locations
Romania, Remote 求人ID R0000029760 Category AdministrativeAbout this Role
The role can be flexibly based in the UK/South Africa and other select EU 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 oversight and delivery of User Acceptance Testing of clinical systems and associated documentation.
What You'll Do At Parexel:
Lead the delivery of User Acceptance Testing of eClinical systems on study level
Create, manage, and negotiate timelines for User Acceptance Testing
Support client account level tasks
Serve as the primary point of contact with the project team for User Acceptance Testing
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
Coordinate the teams responsible for delivery of the User Acceptance Testing for a trial, including design, using standard components, based on customer requirements, planning and coordination of delivery of the technology and input to the overall project plan
Ensure the quality, timeline and budget related to the trial technology meets the project requirements
Set-up trial technologies if appropriate
Ensure project team satisfaction of the User Acceptance Testing
Stay current on the latest Parexel technology offerings, current industry validation methodologies, and relevant clinical trial process developments
Interact with external clients and vendors as needed for discussion on User Acceptance Testing set-up, modifications, and integrations
Demonstrate a proactive approach to providing solutions in a timely manner
Maintain a positive, results oriented work environment, modeling leadership, teamwork, and communicating with team members in an open, balanced, and objective manner
Required skills and experience:
Experience in leading teams in eclinical software testing
Experience in IRT/RTSM and/or Digital Health Technology system delivery
Life science industry experience will be an asset
Ability to create, manage and work to project timelines
Ability to lead through issue identification and successful resolution
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
Fluent English
University degree in relevant discipline
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
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!
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