eClinical Business Lead, Romania (home or office based)

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

This position is available in the following EMEA locations - Romania Poland Serbia South Africa and we offer fully remote home based working.

Picture Yourself At Parexel:

The role leads the implementation of technology at a clinical trials 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 Youll 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

• 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

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program. We offer competitive financial packages training and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.