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 I at Parexel, Hyderabad Onsite

Support Parexel’s clinical trial data management activities in Hyderabad, including data review, cleaning, reconciliation, and database lock preparation. Manage queries, user acceptance testing, and study documentation across Veeva Vault and eTMF.

Descriere

  • Support clinical trial data review, data cleaning, query management, and vendor data reconciliation.
  • Review clinical data listings.
  • Investigate and resolve data discrepancies.
  • Execute CRF freeze and database lock activities.
  • Collaborate with internal and external stakeholders.
  • Perform user acceptance testing for listings, screens, and edit checks.
  • Maintain study records and documentation in Veeva Vault and eTMF.
  • Conduct local laboratory and external data review and reconciliation.
  • Administer clinical data management processes and related study documentation.

Cerințe

  • Bachelor’s degree in life sciences, pharmacy, biotechnology, clinical research, or a related scientific discipline.
  • At least two years of clinical data management experience in a CRO, pharmaceutical, or biotechnology setting.
  • Practical 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.
  • Knowledge of ICH-GCP, regulatory guidelines, and 21 CFR Part 11.
  • Experience with J-Review, Spotfire, Veeva Vault, eTMF, Microsoft Office, Microsoft Project, and PowerPoint.

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