Senior eClinical Business Lead - based in select European locations/South Africa

TN United Kingdom; Uxbridge; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior eClinical Business Lead to spearhead the implementation of their eClinical platform. This role is pivotal in ensuring timely start-up and quality delivery of clinical trials, working closely with project teams and external clients. The ideal candidate will have a strong background in clinical trial systems and a proven ability to manage complex accounts while mentoring junior staff. Join a forward-thinking organization that values innovation and teamwork, and make a significant impact in the clinical research landscape.

Qualifications

• Significant work experience in a CRO/Pharma setting.
• Proven experience in clinical trial systems with understanding of documentation and integrations.
• Knowledge of ICH Guidelines and Good Clinical Practices.

Responsibilities

• Lead implementation of eClinical platform on trial level.
• Train and mentor junior eClinical Business Leads.
• Analyze protocols and collaborate with stakeholders.

Skills

Clinical Trial Systems (CTMS, EDC, RTSM)

Requirements Gathering

Mentoring

Data Integration Solutions

Client Relationship Management

eCOA, ePRO

Data Standards (CDISC SDTM)

Education

Degree in Life Sciences

Degree in Computer Sciences

Job description

Social network you want to login/join with:

Senior eClinical Business Lead - based in select European locations/South Africa, Uxbridge

col-narrow-left

Client:

Parexel

Location:

Uxbridge, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

f0f999ac1e85

Job Views:

6

Posted:

05.05.2025

Expiry Date:

19.06.2025

col-wide

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