Principal Clinical Data Science Lead

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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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• •Competitive base salary and performance related incentives
• •Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• •Retirement and pension plans
• •Life assurance and disability coverage
• •Employee assistance programmes and wellbeing resources
• •Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here .

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