Senior Clinical Data Manager

This is a fully remote position, open to applicants in Poland, +3 more countries.

📋 Description

• Serving as the main data lead within interdisciplinary study teams and sponsor collaborations.

• Leading study start-up initiatives, which encompass EDC configuration, system integrations, user acceptance testing (UAT), and essential data management deliverables.

• Supervising data review, reconciliation, vendor management, and database lock processes.

• Ensuring adherence to CDISC standards, ICH-GCP regulations, and other compliance requirements.

• Recognizing and addressing risks while fostering continuous improvement and operational excellence.

⛳️ Requirements

• A bachelor's degree in Life Sciences, Health Sciences, or a similar field.

• Over 6 years of experience in Clinical Data Management or Clinical Data Science within a Contract Research Organization (CRO) or pharmaceutical setting.

• Demonstrated experience in leading studies throughout the complete clinical trial lifecycle.

• Experience as the primary Data Lead on complicated studies and/or extensive hands-on data review and reconciliation experience across EDC, vendor, eCOA, IRT, and SAE data.

• Strong experience in vendor oversight and stakeholder management.

• Practical experience with EDC systems, preferably Veeva EDC.

• Familiarity with CDISC standards, including SDTM.

• Comprehensive understanding of clinical trial processes, regulatory requirements, and ICH-GCP.

• Exceptional communication, problem-solving, and project leadership abilities.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.