# Senior Clinical Data Science Lead

**Company**: ICON Strategic Solutions
**Location**: Reading
**Experience**: senior
**Job type**: full-time
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/UK-Reading/Senior-Clinical-Data-Science-Lead_JR163549?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

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.

**Responsibilities:**

- 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.

**Requirements:**

- 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.

**Rewards & Benefits:**

- 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

## Skills

### Required
- Clinical Data Management
- Data Analysis
- Interpretation
- Management
- Clinical Trials
- eCRFs
- study metadata
- edit checks
- Data Validation Documents
- protocol deviation documentation
- EDC developers
- SAS programming
- data monitoring activities
- data listings
- extracts
- database closure plans
- ICH
- GCP
- Natural Sciences
- Informatics
- Medical Documentation

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