ICON Strategic Solutions
Senior Clinical Data Science Lead
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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, Spain, Ireland, South Africa
What You Will Do
You will oversee clinical data management activities across the study lifecycle, ensuring deliverables meet quality, compliance, and timeline expectations.
Key Responsibilities Include
- Leading day-to-day clinical data management activities for assigned studies and providing oversight of CROs and external vendors, including laboratories, ECG providers, and imaging vendors.
- Monitoring vendor performance, timelines, and key performance indicators (KPIs), proactively identifying and mitigating data-related risks.
- Reviewing and approving study documentation, including Data Management Plans (DMPs), CRF/eCRF specifications, Data Validation Plans (DVPs), database specifications, and Data Transfer Agreements (DTAs).
- Participating in User Acceptance Testing (UAT) activities for Electronic Data Capture (EDC) systems and ensuring database functionality aligns with protocol requirements.
- Overseeing data quality review, reconciliation activities, query management, medical coding, safety data reconciliation, data cleaning, database lock readiness, and final data transfers.
- Managing clinical data management timelines to support key study milestones, including interim data cuts, analyses, and final database locks.
- Collaborating with cross-functional study teams and external partners to ensure compliance with ICH-GCP guidelines, FDA/EMA regulations, and applicable standard operating procedures.
- Leading study-related meetings with sponsors and vendors, maintaining clear communication and alignment across all stakeholders.
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Your Profile
You will have strong clinical data management experience, with the ability to manage multiple priorities, oversee external partners, and drive high-quality study delivery.
Required Qualifications And Experience
- Bachelor's degree in a scientific, life sciences, healthcare-related, or equivalent discipline.
- Minimum of 5 years of clinical data management experience supporting multicentre clinical studies within the pharmaceutical, biotechnology, or CRO industry.
- Experience working in a sponsor environment or managing sponsor relationships through a CRO partnership model.
- Expertise with leading EDC platforms such as Medidata Rave, Oracle InForm, or Veeva Vault CDMS. Programming knowledge is desirable.
- Strong understanding of CDISC standards, medical coding dictionaries (MedDRA and WHO-DD), and data reconciliation processes.
- Deep knowledge of ICH-GCP guidelines, 21 CFR Part 11 requirements, and clinical data management best practices.
- Excellent communication, stakeholder management, and vendor oversight skills, with the ability to influence outcomes across cross-functional teams.
- Strong analytical and problem-solving abilities, with a track record of identifying and resolving complex data issues and study risks.
- Previous experience supporting tobacco or nicotine-related clinical studies and knowledge of EU clinical regulations would be an advantage.
- Fluent English language skills, both written and verbal.
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.
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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.
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