Clinical Data Analyst II

Parexel International; Hyderabad; Hybrid; INR 900,000 - 1,200,000; Full time

Job summary

Parexel International is seeking a Clinical Data Management Associate with 4+ years of experience to support data review, cleaning, and discrepancy resolution across trials.

The role requires hands-on EDC experience (Medidata RAVE/Oracle Clinical), data reconciliation, and UAT testing, with Veeva Vault/eTMF documentation responsibilities. Hybrid work arrangement in India.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related discipline.
• Minimum 4+ years in Clinical Data Management within CRO/pharma/biotech.
• Hands-on with EDC systems, preferably Medidata RAVE and Oracle Clinical.
• Experience in data review, query management, vendor reconciliation, and database lock activities.
• Working knowledge of clinical research regulations, GCP, and clinical trial processes.
• Experience with Veeva Vault and eTMF documentation preferred.

Responsibilities

• Review clinical data listings and perform data cleaning to resolve discrepancies.
• Manage queries and coordinate data clarification with vendors and internal teams.
• Oversee CRF freeze/lock activities and ensure data integrity for submissions.
• Conduct UAT for listings, screens, and edit checks and document results.
• Maintain study documentation in Veeva Vault/eTMF and support data reconciliation efforts.

Skills

Clinical Data Review

Data Cleaning

Query Management

Reconciliation

UAT

Veeva Vault

Data Review Tools

Communication

Cross-functional Collaboration

Regulatory Knowledge

GCP/21 CFR 11

Education

Bachelor's degree in Life Sciences / Pharmacy / Biotechnology or related field

Tools

Medidata RAVE

Oracle Clinical

J-Review

Spotfire

Veeva Vault

eTMF

Job description

We are seeking a Clinical Data Management Associate with 4+ years of experience to support clinical trial data review, data cleaning, query management, and vendor data reconciliation activities. The role involves reviewing clinical data listings, resolving data discrepancies, performing CRF freeze and lock activities, coordinating with internal and external stakeholders, conducting User Acceptance Testing (UAT), and maintaining study documentation within Veeva Vault/eTMF. The ideal candidate will have hands‑on experience with EDC systems, clinical data review tools, and a strong understanding of clinical research data management processes.

Skillsets

• Clinical Data Review and Data Cleaning
• Clinical Data Listings Review
• Query Management and Discrepancy Resolution
• Vendor Data Reconciliation, including Local Lab Review
• External Data Review and Reconciliation
• CRF Freeze and Lock Activities
• User Acceptance Testing (UAT) for Listings, Screens, and Edit Checks
• eTMF Documentation and Veeva Vault Management
• Clinical Data Workbench Experience
• Knowledge of Clinical Trial Data Management Processes
• Understanding of ICH‑GCP, Regulatory Guidelines, and 21 CFR Part 11
• Cross-functional Collaboration and Stakeholder Management
• Strong Written and Verbal Communication Skills

Tools & Systems:

• EDC: Medidata RAVE (Preferred), Oracle Clinical
• Data Review: J-Review, Spotfire
• Documentation: Veeva Vault, eTMF
• Microsoft Office Suite, Microsoft Project, PowerPoint

Qualification

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific discipline.
• Minimum 4+ years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment.
• Hands‑on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical.
• Experience in data review, query management, vendor reconciliation, and database lock activities.
• Working knowledge of clinical research regulations, GCP guidelines, and clinical trial processes.
• Experience with Veeva Vault and eTMF documentation is preferred.

Location- Hybrid