eClinical Business Lead

The role can be fully home based in Romania, Serbia, Poland, Spain, South Africa

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 the design, requirements gathering, requirements documentation, and configuration.

What You'll Do At Parexel

Project Delivery

• Lead the implementation of the eClinical platform for a study

• Serve as the primary point of contact internally and with external customers as needed regarding study technology, data integrations, and requirements

• Collaborate with Project Leaders, Project Specialists, and other study team members on study technology needs from the point of early trial planning through trial execution if needs change (e.g., under a protocol amendment)

• 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

• Focus on 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

Client Management

• Interact with external clients as needed for discussion on technology set-up, modifications, and integrations

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

• Proven experience in clinical trials (CRO/Pharma)

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

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

• 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

• 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

• Experience or knowledge of data standards such as CDISC SDTM

• Strong ability to work to tight deadlines

• Fluent English

• Educated to a degree level

• Strong customer focus

• Excellent verbal and written communication skills

• Good project management skills

• In depth understanding and experience of clinical trial processes

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

#LI-REMOTE