Clinical Data Analyst II

Parexel · Healthcare & Pharma

India - Hyderabad; India-Bengaluru; India-Mumbai
Hybrid
Posted today
Data & AI

About the job

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Summary

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

Apply on Parexel