Parexel
Parexel
Parexel — жаңа дәрі-дәрмектерді әзірлеудің барлық кезеңдерінде биофармацевтикалық компанияларға қызмет көрсететін жаһандық клиникалық зерттеу ұйымы. Оның қызметі I–IV фазалардағы клиникалық зерттеулерді, портфель мен зерттеулерді басқаруды, реттеуші стратегияны, нарыққа қолжетімділікті және дәрі-дәрмектің өмірлік циклін жоспарлауды қамтиды. 21 000-нан астам маманы бар Parexel клиникалық, реттеуші және терапиялық сараптаманы пациенттер туралы түсініктермен және инновациялық зерттеу үлгілерімен ұштастырады. Компания онкология, нейроғылым және сирек кездесетін ауруларды қоса алғанда, әртүрлі бағыттардағы зерттеулерге қолдау көрсетіп, клиникалық әзірлеу үдерісін тиімдірек әрі пациентке бағдарланған етуге назар аударады.

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.

Сипаттама

  • 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

Талаптар

  • 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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