eClinical Business Lead - based in the UK / South Africa or selected EU locations

Parexel; España; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A global clinical trials organization is seeking a professional to lead the implementation of technology for clinical trials. The role involves ensuring timely project start-up, managing system configurations, and collaborating with various stakeholders. The ideal candidate will have proven experience in clinical trials, strong project management skills, and fluency in English. This position requires a proactive approach to problem-solving and attention to detail.

Formación

• Proven experience in clinical trials (CRO / Pharma).
• Ability to develop awareness of Clinical Research Services.
• Experience in configuration of clinical trial systems.
• Knowledge of SOPs / Guidelines / System Life Cycle methodologies.
• Strong ability to work to tight deadlines.

Responsabilidades

• Lead implementation of the eClinical platform for studies.
• Serve as primary contact for study technology and integrations.
• Collaborate with teams on technology needs throughout trial.
• Analyze protocols and review user requirements.

Conocimientos

Clinical trial experience

Virtual team coordination

Knowledge of clinical trial systems

Project management skills

Excellent communication skills

Strong customer focus

Attention to detail

Fluent English

Descripción del empleo

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 :

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

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

Here are a few requirements specific to this advertised role :

Proven experience in clinical trials (CRO / Pharma).

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.

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

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.

Strong customer focus.

Excellent verbal and written communication skills.

Good project management skills.

In depth understanding and experience of clinical trial processes.

Proven ability to manage independently competing priorities with attention to detail.

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