Parexel
Parexel
Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.

Clinical Data Analyst II at Parexel – Hyderabad Hybrid

Support Parexel clinical trials through data review, cleaning, reconciliation, and query management. The role also covers database locks, UAT, and Veeva Vault documentation.

Descriere

  • Support clinical trial data review, cleaning, query management, and vendor data reconciliation
  • Review clinical data listings
  • Investigate and resolve data discrepancies
  • Complete CRF freeze and database lock activities
  • Coordinate with internal and external stakeholders
  • Conduct UAT for listings, screens, and edit checks
  • Maintain study documentation in Veeva Vault/eTMF
  • Review and reconcile local laboratory and other external data

Cerințe

  • At least four years of Clinical Data Management experience in a CRO, pharmaceutical, or biotechnology setting
  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific field
  • Hands-on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical
  • Experience with data review, query management, vendor reconciliation, and database lock activities
  • Working knowledge of clinical research regulations, GCP guidelines, and clinical trial processes
  • Veeva Vault and eTMF documentation experience is preferred
  • Experience using clinical data review tools
  • Knowledge of ICH-GCP, regulatory guidelines, and 21 CFR Part 11
  • Experience with Clinical Data Workbench
  • Strong written and verbal communication abilities

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