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eClinical Business Lead, UAT Lead - select EMEA locations

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 
South Africa, United Kingdom, EMEA

Offer summary

Qualifications:

University degree in relevant discipline, Experience in leading eclinical software testing teams, Knowledge of clinical trial regulations and guidelines, Strong customer focus and communication skills.

Key responsabilities:

  • Lead User Acceptance Testing for eClinical systems
  • Manage project timelines and coordinate teams
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Parexel XLarge http://www.parexel.com
10001 Employees
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Job description

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 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 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

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!

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Timelines
  • Problem Solving
  • Communication
  • Teamwork
  • Detail Oriented

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