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

📋 Description

• Serve as the primary data leader 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.

• Manage data review, reconciliation, vendor oversight, and database locking procedures.

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

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

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

⛳️ Requirements

• A 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 as the primary Data Lead on complex studies, along with substantial hands-on data review and reconciliation expertise across EDC, vendor, eCOA, IRT, and SAE data.

• Strong experience in vendor supervision and stakeholder management.

• Practical experience with EDC systems, preferably with Veeva EDC.

• Familiarity with CDISC standards, particularly SDTM.

• In-depth understanding of clinical trial processes, regulatory obligations, and ICH-GCP standards.

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

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