eClinical Business Lead, UAT Lead

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:

• 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
  
  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
  
  When you join us, you're joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there's no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change - forever. And together, we'll do it With Heart ., Parexel is among the world's largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.
  
  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!