eClinical Business Lead, IRT/eCOA Design - UK

Picture Yourself At Parexel:

The role provides consultation on the Randomization and Trial Supply Management (RTSM) and Digital Health Technology (DHT e.g., eCOA, eConsent) system design, analysing study protocols and collaborating with stakeholders to create user requirements to meet the needs of the study. This individual is responsible for identifying and mitigating risks related to RTSM and DHT design and ensuring that the overall deliverables align with internal and external client expectations.

In addition, this role provides oversight of and conducting of User Acceptance Testing (UAT) on RTSM and Digital Health Technology (e.g., eCOA, eConsent) systems. This individual ensures project management and technical skills are utilized to timely manage UAT for projects, meeting budget and quality standards.

What You'll Do At Parexel:

Project Delivery

• Provide consultation to Project Leaders and other study team members on RTSM and DHT study design.

• Analyse protocols and collaborate with all stakeholders to create and review User Requirements and ensure they meet the needs of the study design.

• Identify and mitigate any risks related to RTSM and DHT study design.

• Translate complex RTSM and DHT requirement descriptions into language that can be understood by study team to aid in their decision making and understanding of project functionality.

• Understand the various integrations that can interface with RTSM and DHT, and proactively help identify any potential integration user requirements issues.

• Work closely with UAT Leads.

• Stay current on RTSM and DHT technology and relevant clinical trial process developments in the industry and requirements within Parexel.

• Manage quality control and timely delivery of project deliverables and appropriate remedial action.

Client Management

• Interact with external clients as needed for discussion on RTSM and DHT design and protocol elements.

• Demonstrate a proactive approach to providing solutions in a timely manner.

General Admin

• 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:

• At least 12 months experience in IRT/RTSM and/or Digital Health Technology system delivery.

• Ability to develop detailed awareness of Clinical Research Services, external vendor software and tools with practical knowledge of how these applications work and provide efficiency to operations.

• Experience in clinical trial systems (e.g, CTMS, EDMS, EDC, IRT, reporting tools) and in configuration of these systems.

• Ability to work autonomously.

• Global virtual team coordination experience for trial technology set-up.

• Good project management skills.

• Excellent verbal and written communication skills.

• 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.

• Awareness/experience in the needs and use of data standards in clinical trial environment; if possible, knowledge of data standards such as CDISC SDTM.

• In depth understanding and experience of clinical trial processes.

• Demonstrated adeptness in learning new systems and function in an evolving technical environment.