This is a fully remote position, open to applicants in Poland, +2 more countries.

📋 Description

• Serve as the principal data lead within interdisciplinary study teams and sponsor collaborations.

• Lead study initiation processes including EDC configuration, system integrations, user acceptance testing (UAT), and essential data management deliverables.

• Supervise data evaluation, reconciliation, vendor management, and database closure activities.

• Ensure adherence to CDISC standards, ICH-GCP guidelines, and regulatory requirements.

• Recognize and address risks while promoting continuous improvement and operational excellence.

• Act as the main data lead for global clinical trials, collaborating closely with sponsors to ensure high-quality, regulatory-compliant data delivery from study initiation through to database closure.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Health Sciences, or a related field.

• Over 6 years of experience in Clinical Data Management or Clinical Data Science within a CRO or pharmaceutical setting.

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

• Experience serving as the primary Data Lead on complex studies and/or extensive practical data review and reconciliation across EDC, vendor, eCOA, IRT, and SAE data.

• Strong experience in vendor oversight and stakeholder management.

• Practical experience with EDC systems, with a preference for Veeva EDC.

• Familiarity with CDISC standards, including SDTM.

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

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

• Legal authorization to work in the country where the position is based.