Clinical Data Management II

Parexel

Our job posting describes a Clinical Data Management II role at Parexel, a leading global clinical research organization (CRO). The position is based in India with hybrid work arrangement and involves supporting the delivery of high-quality clinical trial data across multiple studies. The candidate will work with cross-functional teams, CRO partners, and external vendors to review data, resolve discrepancies, reconcile external data sources, and support database lock activities. This role emphasizes data quality, regulatory compliance, and collaboration to advance clinical research.

About this Role

About Parexel

Parexel is a leading global clinical research organization (CRO) committed to advancing clinical research and improving patient outcomes worldwide. We partner with biopharmaceutical companies, medical device manufacturers, and academic institutions to conduct high-quality clinical trials and deliver innovative solutions across all phases of development. Our multidisciplinary team of experts is dedicated to ensuring regulatory compliance, scientific excellence, and operational efficiency in every project we undertake.

About the Role

We are seeking a highly motivated Clinical Data Management II with 4+ years of experience to support the delivery of high-quality clinical trial data across multiple studies. This role offers an opportunity to contribute to critical clinical research programs by ensuring the accuracy, integrity, and completeness of clinical data used to support regulatory submissions and evidence-based decision-making.

The successful candidate will work collaboratively with cross-functional teams, CRO partners, and external vendors to review clinical data, resolve discrepancies, reconcile external data sources, and support database lock activities. This position is ideal for professionals who are detail-oriented, thrive in a collaborative environment, and are passionate about advancing clinical research through excellence in data management.

Key Responsibilities

• Perform clinical data review and data cleaning activities to ensure data quality and consistency across studies.

• Review clinical data listings and identify data discrepancies requiring investigation or follow-up.

• Manage and resolve data queries in collaboration with investigative sites, study teams, and vendors.

• Conduct vendor data reconciliation activities, including local laboratory data review and reconciliation.

• Review and reconcile external data sources to ensure completeness and accuracy.

• Support CRF freeze and database lock activities in accordance with study timelines and procedures.

• Execute User Acceptance Testing (UAT) for data listings, review screens, edit checks, and related system enhancements.

• Maintain study documentation within Veeva Vault and eTMF systems in compliance with organizational and regulatory requirements.

• Utilize clinical data review platforms to analyze study data and identify potential data quality issues.

• Collaborate with clinical operations, biostatistics, programming, medical, and external partners to support effective study execution.

• Ensure compliance with ICH-GCP, applicable regulatory requirements, and 21 CFR Part 11 standards.

• Contribute to process improvements that enhance efficiency, quality, and compliance within data management activities.

• Preferred Technical Skills

• Clinical Data Management

• Clinical data review and cleaning

• Query management and discrepancy resolution

• Vendor data reconciliation

• Database lock activities

• User Acceptance Testing (UAT)

• Tools & Systems

• Medidata RAVE (preferred)

• Oracle Clinical

• J-Review

• Spotfire

• Veeva Vault/eTMF

• Microsoft Office Suite

• Required Qualifications

• 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.

• Location: Hybrid - India

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