eClinical Business Lead – based in Romania, Serbia, Poland, Spain, South Africa

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 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

Here are a few requirements specific to this advertised role:

• 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

Originally posted on Himalayas