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

The Clinical Data Management Associate will support the Data Management Lead
(DML) in the planning, setup, execution, monitoring, and closeout of clinical
studies. The role is responsible for database build activities, data review,
vendor oversight, study documentation, quality management, and ensuring
high-quality clinical data delivery in compliance with regulatory requirements,
SOPs, and study timelines.

Key Skills & Experience

* 8+ years of End-to-end Clinical Data Management experience from protocol
review,



CRF/eCRF design through database lock.

* Strong experience in EDC systems: Medidata RAVE and Oracle Clinical.

* Expertise in Data Review, Query Management, Query Trend Analysis, Protocol
Deviation Review, and Data Quality oversight.

* Experience authoring and reviewing DQMP, DVP, DRP, PDRP, eCRF Completion
Guidelines, and related study documents.

* Knowledge of FDA/ICH-GCP guidelines, clinical drug development process, and
regulatory submission requirements.

* Experience overseeing CRO/CDM vendors and managing study deliverables within
timelines.

* Robust project management, metrics reporting, and stakeholder management
skills.

* Experience supporting audits, inspections, and cross-functional study teams.

* Excellent communication, mentoring, and leadership abilities.

Key Responsibilities

* Support DML in study planning, execution, and project management activities.

* Draft EDC build timelines a

📌 Senior Clinical Data Analyst (Hyderabad)
🏢 Parexel
📍 Hyderabad