e-Clinical Business Lead – select UK/EU locations

·
Full time
Location: Uxbridge
·
Job offered by: Parexel
·
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 based in select European locations.

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: Serve as the single point of contact with the project team for trial-level technology and data integration solutions, covering Clinical Research Services and technology third-party vendors. Define and document requirements for the trial technology. Be accountable for all technology set-up for assigned trials; this includes working with colleagues across departments who have specific responsibilities for part of the set-up. Coordinate the teams responsible for delivery of the technology for a trial, including design, using standard components, based on customer requirements, planning and coordination of delivery of the technology and input to the overall project plan. Ensure the quality, timeline, and budget related to the trial technology meet the project requirements. Escalate requests or requirements for non-standard technology to the assigned Client Technology Partner. Set-up trial technologies if appropriate. Ensure project team satisfaction of the trial technology solution. Train and mentor junior eClinical Business Analysts. Stay updated on technology and clinical trial process developments and requirements within Parexel. Ideal candidate will possess: Proven experience in clinical trials. 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. 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. Proven ability to manage independently competing priorities with attention to detail. Demonstrated adeptness in learning new systems and function in an evolving technical environment.

#J-18808-Ljbffr

Recent Jobs

London (On site) · Full time

Are you a smart, driven professional who takes pride in making a difference in local communities? Turner & Townsend’s Real Estate division is experiencing significant growth and we’re looking for an experienced industry professional with health project experience to join our high-performing and collaborative Project Management team. Why Join Us? Impactful Work: Contribute to social [...]Read More... from Assistant Project Manager – Healthcare See details

Chasetown (On site) · Full time

My client, Autosmart International are a manufacturing success story! Site Operations Manager – leading fast-paced manufacturing and warehousing About Our Client Autosmart International is a manufacturing success story, leading the field in vehicle cleaning products. We are the No.1 choice of automotive trade customers across the UK. We have doubled in size in the last [...]Read More... from Site Operations Manager See details

London (On site) · Full time

CSS are looking for an experienced duty officer to join our client’s team who are a local council responsible for all areas within the Tendering district. Working hours: All shifts are 8 hours long with various start times available: Monday to Friday – start times between 6AM – 3PM Saturday & Sunday – 6AM – [...]Read More... from Duty Officer See details