Senior Clinical Data Science Lead

 Posted 9 hours ago
  
 Poland
  
5-10 years experience
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AI Summary

Lead the analysis, interpretation, and management of clinical data across global trials to ensure regulatory compliance and high-quality delivery. Oversee study start-up activities, data cleaning, and database lock processes while partnering with sponsors and cross-functional teams.
Senior Clinical Data Science Lead

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


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.

Key Responsibilities

  • Lead clinical data science activities across global clinical trials, ensuring high-quality, timely, and regulatory-compliant data delivery
  • Act as the primary data lead within cross-functional study teams, partnering with sponsors and internal stakeholders
  • Ensuring alignment with agreed timelines, scope, and quality expectations
  • Drive study start-up activities including EDC build, system integrations (ePRO, IRT, eCOA), and user acceptance testing (UAT)
  • Lead the development and execution of key data documentation such as Data Management Plans, Data Review Plans, and Edit Check Specifications
  • Oversee data cleaning, query management, and cross-functional data review processes
  • Manage external data reconciliation and vendor data integration activities
  • Lead database lock activities (interim and final), ensuring inspection readiness and data integrity
  • Identify and mitigate risks, proactively resolving complex data-related issues and escalations
  • Ensure compliance with CDISC standards, ICH-GCP, and regulatory requirements
  • Contribute to budget management, KPI tracking, and continuous improvement initiatives
  • Drive innovation through adoption of new technologies and data science approaches

Your Profile: Required Qualifications and Experience

  • Bachelor’s degree in Life Sciences, Health Sciences, or related discipline
  • Extensive experience (typically 6–10+ years) in clinical data management or clinical data science within a CRO or pharmaceutical environment
  • Proven ability to lead data activities across full clinical trial lifecycle (start-up, conduct, and close-out)
  • Strong experience in vendor oversight and management of outsourced data delivery models
  • Expert knowledge of clinical data standards, including CDISC (SDTM preferred)
  • In-depth understanding of clinical trial processes, regulatory frameworks (ICH-GCP, FDA), and data workflows
  • Hands-on experience with EDC systems (e.g., Veeva EDC preferred) and external data integrations
  • Experience with regulatory submissions (NDA/CTD) is an advantage
  • Strong project management, organizational, and problem-solving skills
  • Excellent communication and ability to influence stakeholders in a matrix environment
  • Ability to work independently, proactively manage risks, and thrive in fast-paced, global teams

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.

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

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