Senior Clinical Data Lead: EDC, SDTM & Study Delivery

ICON Strategic Solutions; Warszawa; On-site; PLN 300,000 - 420,000; Full time

Benefits offered by this job

Health insurance

Annual leave & flexible benefits

Retirement planning

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Senior Manager, Clinical Data Management. You will be the primary data lead across global trials, driving high-quality, regulatory-compliant data delivery from study start-up through database lock.

Lead cross-functional teams, manage vendors, and ensure adherence to CDISC SDTM standards and ICH-GCP. A challenging role with global sponsor partnerships and opportunities for impact.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, or a related discipline.
• 6+ years of Clinical Data Management or Clinical Data Science experience within a CRO or pharmaceutical environment.
• Proven experience leading studies across the full clinical trial lifecycle.
• Experience as a primary Data Lead on complex studies and/or extensive hands-on data review and reconciliation across EDC, vendor, eCOA, IRT, and SAE data.
• Strong vendor oversight and stakeholder management experience.
• Hands-on experience with EDC systems, with Veeva EDC preferred.
• Knowledge of CDISC standards, including SDTM.
• Strong understanding of clinical trial processes, regulatory requirements, and ICH-GCP.
• Excellent communication, problem-solving, and project leadership skills.

Responsibilities

• Acting as the primary data lead within cross-functional study teams and sponsor partnerships.
• Driving study start-up activities including EDC build, system integrations, UAT, and key data management deliverables.
• Overseeing data review, reconciliation, vendor management, and database lock activities.
• Ensuring compliance with CDISC standards, ICH-GCP requirements, and regulatory expectations.
• Identifying and mitigating risks while driving continuous improvement and operational excellence.

Skills

Data management

Project leadership

Vendor oversight

Communication

Regulatory knowledge

Education

Bachelor's degree in Life Sciences/Health Sciences

Tools

Veeva EDC

EDC systems

Job description

ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Senior Manager, Clinical Data Management. You will be the primary data lead across global trials, driving high-quality, regulatory-compliant data delivery from study start-up through database lock.

Lead cross-functional teams, manage vendors, and ensure adherence to CDISC SDTM standards and ICH-GCP. A challenging role with global sponsor partnerships and opportunities for impact.