Senior Clinical Data Science Lead

Posted 9 Days Ago
Be an Early Applicant
Warsaw, Warszawa, Mazowieckie, POL
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Lead clinical data science across global trials: own EDC builds, integrations, UAT, data documentation, cleaning, vendor reconciliation, and database locks while ensuring CDISC/ICH-GCP compliance, driving innovation, managing risks, and partnering with sponsors and cross-functional teams to deliver regulatory-ready data.
Summary Generated by Built In
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

Skills Required

  • Bachelor's degree in Life Sciences, Health Sciences, or related discipline
  • 6-10+ years experience 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, close-out)
  • Experience in vendor oversight and management of outsourced data delivery models
  • Expert knowledge of clinical data standards (CDISC)
  • Familiarity with SDTM (preferred)
  • In-depth understanding of clinical trial processes, regulatory frameworks (ICH-GCP, FDA), and data workflows
  • Hands-on experience with EDC systems and external data integrations (Veeva EDC preferred)
  • Experience with regulatory submissions (NDA/CTD)
  • Strong project management, organizational, and problem-solving skills
  • Excellent communication and stakeholder influence in a matrix environment
  • Ability to work independently, manage risks proactively, and perform in fast-paced global teams

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Similar Jobs

Mondelēz International Logo Mondelēz International

Manager, Procurement Data Science and Analytics (F/M/X)

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Remote or Hybrid
3 Locations
90000 Employees

Mondelēz International Logo Mondelēz International

Learning & Development Lead

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Hybrid
9 Locations
90000 Employees

Capco Logo Capco

Development Engineer

Fintech • Professional Services • Consulting • Energy • Financial Services • Cybersecurity • Generative AI
Remote or Hybrid
Poland
6000 Employees

Capco Logo Capco

Senior Business Analyst

Fintech • Professional Services • Consulting • Energy • Financial Services • Cybersecurity • Generative AI
Remote or Hybrid
Poland
6000 Employees

Similar Companies Hiring

Granted Thumbnail
Mobile • Insurance • Healthtech • Financial Services • Artificial Intelligence
New York, New York
23 Employees
Fortune Brands Innovations Thumbnail
Manufacturing
Deerfield, IL
10000 Employees
Amalgamated Sugar Thumbnail
Food • Greentech • Agriculture • Industrial • Manufacturing
Boise, Idaho
768 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account