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.

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.
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