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eClinical Business Lead

2 months ago

Bloemfontein, Orange Free State, South Africa Parexel Full time

About This Role

The eClinical Business Lead will lead 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.

Key Responsibilities

  • Lead the UAT Testing of the eClinical platform for a study
  • Serve as the primary point of contact internally and with external customers as needed for UAT delivery
  • Collaborate with Project Leaders, Project Specialists, and other study team members on UAT Testing needs from the point of early trial planning through trial execution
  • Analyze protocols and collaborate with all stakeholders to create and review user requirements and integration needs from the perspective of UAT testing
  • Identify and mitigate any risks related to system set-up and integrations with internal systems and/or sponsor systems and implement appropriate testing scenarios to mitigate risks
  • Foster a culture of 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
  • Interact with external clients as needed for discussion on technology set-up, UAT testing, modifications, and integrations
  • Demonstrate a proactive approach to providing solutions in a timely manner
  • 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 and in compliance with relevant guidelines

Requirements

  • Several years of life science industry experience (CRO/Pharma)
  • Experience in leading 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