Parexel
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Pharmaceutical
Design, build, and maintain clinical trial databases (EDC/CDMS); program and validate edit checks; annotate eCRFs; integrate third‑party systems; document per SOPs/ICH‑GCP/21 CFR Part 11; support project technical queries and contribute to standards and process improvements.
Pharmaceutical
Lead clinical database setup, eCRF design, edit check programming and integration of third-party systems for EDC/CDMS. Serve as SME, technical/technical lead, mentor teams, ensure regulatory compliance (ICH-GCP, 21 CFR Part 11), monitor quality/timelines/budgets, support business development and global initiatives.
3 Hours AgoSaved
Pharmaceutical
Dedicated CRA supporting oncology studies for a single sponsor in Poland. Responsible for full site management and supervision, ensuring GCP/ICH and local regulatory compliance, mentoring junior CRAs, and performing independent site monitoring. Home-based with travel opportunities and use of sponsor systems and technology to support clinical development.
