Parexel
Parexel
Parexel एक वैश्विक क्लिनिकल रिसर्च संगठन है, जो नई दवाओं के विकास के दौरान बायोफार्मास्यूटिकल कंपनियों को सेवाएँ प्रदान करता है। इसका कार्य चरण I–IV क्लिनिकल परीक्षणों, पोर्टफोलियो और परीक्षण प्रबंधन, नियामक रणनीति, बाज़ार तक पहुँच तथा जीवनचक्र योजना तक फैला हुआ है। 21,000 से अधिक पेशेवरों के साथ, Parexel क्लिनिकल, नियामक और उपचार-विज्ञान संबंधी विशेषज्ञता को मरीजों की अंतर्दृष्टि और नवीन परीक्षण डिज़ाइनों के साथ जोड़ता है। कंपनी ऑन्कोलॉजी, न्यूरोसाइंस और दुर्लभ रोगों सहित विभिन्न क्षेत्रों में अनुसंधान का समर्थन करती है और क्लिनिकल विकास को अधिक कुशल तथा मरीज-केंद्रित बनाने पर ध्यान देती है।

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.

विवरण

  • 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.

आवश्यकताएँ

  • 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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