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Clinical Data Analyst II
応募 求人ID R0000044587 ロケーション ハイデラバード, テランガーナ州 仕事内容Job Summary
We are seeking an experienced Clinical Data Analyst with 4+ years of clinical data management experience to support data review, data cleaning, study build activities, vendor reconciliations, and database lock processes across global clinical trials. The role will be responsible for reviewing clinical data listings, managing data discrepancies, supporting CRF (Case Report Forms) and edit check development, conducting UAT (User Acceptance Testing) activities, reviewing complex external data sources, and ensuring compliance with GCP and regulatory requirements. The successful candidate will collaborate with cross-functional teams, mentor junior CDM (Clinical Data Management) staff, and contribute to high-quality study delivery across therapeutic areas such as Oncology, Hematology, Cardiovascular, Fibrosis, and Cell Therapy.
Skillsets
- Minimum 4+ years of experience in Clinical Data Review and Clinical Data Management.
- Hands-on experience with Medidata RAVE and other EDC (Electronic Data Capture) systems.
- Experience supporting study build activities, including CRF design, edit checks, and integrations.
- Experience performing UAT during study build and validation phases.
- Strong experience in vendor reconciliation and external data review.
- Experience with database lock activities, including CRF freeze and lock processes.
- Knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
- Experience working within Veeva Vault and eTMF environments.
- Experience in Oncology, Hematology, Cardiovascular, Fibrosis, and/or Cell Therapy studies preferred.
- CCDM Certification is advantageous.
- Stable employment history with tenure of at least one year with previous employers or a valid explanation for transitions.
Qualification
Bachelor's Degree in Life Sciences, Pharmacy, Clinical Research, Biotechnology, or a related field.
