Principal Clinical Data Science Lead

KCR Placement; Reading; Hybrid; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance options

Retirement planning

Job summary

ICON Strategic Solutions is seeking a Principal Clinical Data Science Lead in the UK or South Africa. You will oversee global data management for sponsor-driven studies, developing data management components and ensuring timely, high-quality data delivery.

Strong leadership, communication, and regulatory knowledge are essential as you guide cross-functional teams through early study start-up to database closure.

Qualifications

• Bachelor’s degree or equivalent in Natural Sciences, Informatics, Medical Documentation, or related discipline.
• 5+ years of experience as a Clinical Data Manager with responsibility on clinical projects.
• Strong understanding of the drug development process and clinical data management methodologies.
• Experience managing data from start-up to clean database declaration.

Responsibilities

• Lead Clinical Data Management activities across studies from start-up to database closure.
• Provide oversight and guidance to Data Management staff and mentor colleagues.
• Act as escalation point for data management matters in global study teams.
• Develop and maintain study-specific data management components (eCRFs, metadata, edit checks).
• Collaborate with EDC developers on eCRF design and database structures; contribute to UAT.
• Coordinate SAS programming for edit checks and data monitoring.

Skills

Clinical Data Manager

Data management

Cross-functional teamwork

Ethics and compliance

Education

Bachelor's degree

Tools

EDC

SAS

Job description

Principal Clinical Data Science Lead

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

Principal Clinical Data Science Lead

UK or South Africa

What You Will Be Doing:

• Leading Clinical Data Management activities across assigned studies, from study start-up through to database closure and clean database declaration.
• Providing oversight and guidance to Data Management staff assigned to specific protocols, including mentoring and training less experienced colleagues.
• Acting as an experienced Clinical Data Management resource for global, cross-functional study teams and serving as an escalation point for study-related data management matters.
• Developing and maintaining study-specific data management components and specifications, including eCRFs, study metadata, edit checks, Data Validation Documents and protocol deviation documentation.
• Collaborating with EDC developers on the specification and design of eCRFs and database structures and contributing to EDC User Acceptance Testing (UAT).
• Managing data cleaning activities, including identifying and issuing queries, incorporating query responses, tracking query status and performing consistency checks on external data.
• Coordinating SAS programming requirements for edit checks and derivations and contributing to the preparation of data monitoring activities.
• Preparing data listings and extracts to support medical reviews, study reporting and other cross-functional activities.
• Developing and coordinating database closure plans and ensuring database closure activities are effectively communicated and delivered across the study team.
• Identifying and communicating issues that could impact study timelines or data quality and working collaboratively with study teams to address them.
• Ensuring Clinical Data Management activities are appropriately documented throughout the lifecycle of the study.
• Supporting training and education initiatives for Data Management colleagues to promote quality, productivity and consistent working practices.

Your Profile:

• Bachelor’s degree or equivalent in Natural Sciences, Informatics, Medical Documentation, or a related discipline.
• 5+ years of experience as a Clinical Data Manager, with significant responsibility within clinical projects and study teams.
• Strong understanding of the drug development process and extensive experience with clinical data management methodologies and technologies.
• Proven experience managing clinical data from study start-up through to clean database declaration.
• Experience working within global, cross-functional teams and collaborating with functions such as Study Management, Medical, EDC Development, Statistics and Medical Writing.
• Demonstrated ability to interpret Clinical Study Protocols, Statistical Analysis Plans and Medical Review Plans and translate these into appropriate data management specifications.
• Experience developing specifications including CRFs, metadata, protocol deviation documents and edit check specifications.
• Good understanding of relevant clinical research regulations and guidelines, including ICH and GCP.
• Experience training and/or mentoring junior Data Management colleagues, with the ability to provide guidance and act as an escalation point.
• Experience working within and helping lead global, cross-functional teams towards key study milestones such as First Patient First Visit readiness and timely clean database declaration.
• Strong written and verbal communication skills in English, with fluent spoken English required, alongside strong local-language communication skills.

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here