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Senior eClinical Business Lead - based in select European locations/South Africa, Uxbridge
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Client:
Parexel
Location:
Uxbridge, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
f0f999ac1e85
Job Views:
6
Posted:
05.05.2025
Expiry Date:
19.06.2025
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Job Description:
When our values align, there's no limit to what we can achieve.
Role context:
The role leads the implementation of the eClinical Platform on study level ensuring timely start-up, quality delivery, and compliance with the study protocol and client contracted services. The senior eClinical Business Lead has global responsibility for the design, requirements gathering, requirements documentation, and the accountability for the implementation of technology to meet the specific needs of the assigned trials. This individual will work with Parexel’s standard technology. The Senior eClinical Business Lead provides training and mentoring to the more junior individuals, and take on the more challenging and complex accounts, and may provide work direction to eClinical Business Leads
Role responsibilities
Lead the implementation of the eClinical platform on trial level
Train and mentor more junior eClinical Business Lead
May provide work direction to more junior eClinical Business Leads
Take ownership for the more complex and challenging accounts
Serve as the primary point of contact with the project team for trial-level technology, and data integration solutions, covering CRS, IT, and technology third party vendors
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
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 meets the project requirements
Set-up trial technologies if appropriate
Ensure project team satisfaction of the trial technology solution
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
Maintain a positive, results oriented work environment, modeling teamwork and communicating with team members in an open, balanced, and objective manner
Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices
Role requirements:
Proven significant work experience in a CRO/Pharma setting (operational or technical)
Proven experience in clinical trial systems (e.g., CTMS, EDC, RTSM) with detailed understanding of requirements gathering, documentation, configuration, and integrations
Knowledge in clinical research industry, including detailed understanding of clinical technology, design, and system requirements
Proven record of influencing a team to deliver according to a schedule
Experience of mentoring or providing work direction to staff
Ability to motivate and work effectively with virtual teams within different cultural environments
eCOA, ePRO experience is a plus
Knowledge/experience of data standards such as CDISC SDTM is a plus
Educated to degree level in life sciences and/or computer sciences
Proven ability to manage independently competing priorities with attention to detail
Ability to resolve issues independently with good judgement to escalate appropriately
Proven awareness/experience in the needs and use of data standards in clinical trial environment
Client focused (internal and external) and demonstrating an ability to create and maintain trust with clients
Knowledgeable in ICH and GCP regulations in relevant geographies
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