Senior Clinical Data Science Lead

KCR Placement; Reading; Hybrid; GBP 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme,

Life assurance

Flexible country-specific benefits

Zusammenfassung

ICON Strategic Solutions is seeking a Senior Clinical Data Science Lead to head analysis, interpretation, and management of clinical data for trials in a sponsor-dedicated model. You will oversee data science workstreams, ensuring quality and timely deliverables across global teams.

The role requires 5+ years in clinical data management, strong knowledge of ICH/GCP guidelines, and experience with CRFs, metadata, and eCRF design. Flexible location in the UK or remote, with global collaboration.

Qualifikationen

• 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 in clinical projects and study teams.
• Strong understanding of the drug development process and experience with clinical data management methodologies and technologies.
• Experience managing data from start-up through to clean database declaration.
• Experience in global, cross-functional teams with Study Management, Medical, EDC Development, Statistics and Medical Writing.
• Ability to interpret Clinical Study Protocols, SAPs and Medical Review Plans and translate into data management specs.
• Experience developing CRFs, metadata, protocol deviation documents and edit check specs.
• Understanding of ICH and GCP.
• Experience mentoring junior Data Management colleagues; ability to provide guidance.
• Strong project management, organizational and self-management skills; able to work independently.
• Experience leading cross-functional teams toward milestones like First Patient First Visit readiness and clean database declaration.
• Strong written and verbal English; good local-language skills.
• Understanding of IT processes and databases used in Clinical Development.
• Proactive approach to continuous learning and professional development.

Aufgaben

• Lead Clinical Data Management activities across studies from start-up to database closure.
• Provide oversight and mentoring to Data Management staff on protocols and projects.
• Act as a senior DCM resource for global study teams and escalation point for data management issues.
• Develop and maintain study-specific data management components (eCRFs, metadata, edit checks, data validation docs, protocol deviation docs).
• Collaborate with EDC developers on eCRF specifications and DB structures; contribute to EDC UAT.
• Manage data cleaning activities, including queries and consistency checks on external data.
• Coordinate SAS programming for edit checks and data derivations; support data monitoring activities.
• Prepare data listings/extracts for medical reviews and study reporting.
• Coordinate database closure plans; ensure communication across study team.
• Identify issues impacting timelines/data quality and work with teams to address them.
• Ensure documentation throughout the lifecycle; support training for Data Management colleagues.

Kenntnisse

Clinical Data Management

Study start-up to database closure

Regulatory knowledge (ICH/GCP)

Cross-functional collaboration

Data cleaning & query resolution

CRFs, metadata & edit checks

Mentoring & training

EDC systems / SAS programming

Communication in English

Data monitoring & data listings

Ausbildung

Bachelor’s degree or equivalent in Natural Sciences, Informatics, Medical Documentation

Tools

SAS

EDC systems

Clinical data management software

Jobbeschreibung

Senior 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.

Senior Clinical Data Science Lead - Sponsor Dedicated

UK or South Africa

As a Senior Clinical Data Science Lead at ICON, you will lead the analysis, interpretation, and management of clinical data to drive the success of our clinical trials.

You will oversee clinical data science workstreams, ensuring deliverables meet quality and timeline expectations.

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.
• Strong project management, organisational and self-management skills, with the ability to work independently and effectively manage priorities.
• 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.
• Good understanding of IT processes and databases used within Clinical Development.
• A proactive approach to continuous learning and professional development.

#LI-JC3

#LI-Remote

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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply