Clinical Data Manager

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

📋 Description

• Oversee or co-oversee data management tasks throughout assigned studies from initiation to completion.

• Execute EDC data assessments, data cleansing, query oversight, and the reconciliation of external data sources.

• Develop and update study documentation, which includes Data Management Plans, Data Review Plans, eCRF Completion Guidelines, and Edit Check Specifications.

• Perform EDC and data validation listing UAT, and assist in ensuring database lock preparedness.

• Collaborate with study teams and vendors to address data challenges, including discrepancies in eCOA, PK, biomarker, local laboratory, and safety data.

• Aid in the reconciliation of SAEs and protocol deviations, maintain issue logs, report metrics, and manage eTMF filing.

• Operate within a cooperative client-focused model for a global pharmaceutical partner.

⛳️ Requirements

• Bachelor's degree in a Life Sciences-related field.

• Over 5 years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology setting.

• Proven experience in leading or co-leading studies from initiation through to database lock and finalization.

• Strong practical experience in EDC review, data cleansing, query management, external data reconciliation, and UAT.

• Excellent communication abilities and the capacity to work autonomously within dynamic global study teams.

• Employment is contingent upon possessing the legal right to work in the country where the position is located.

• Experience with Veeva EDC is preferred but not mandatory.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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