Clinical Data Analyst II

Parexel; Hyderabad; Hybrid; INR 1,200,000 - 2,500,000; Full time

Job summary

Parexel in India is seeking a Clinical Data Management II to join our hybrid team. As a Clinical Data Management Associate, you will support data review, cleaning, and query management to advance trial data integrity and regulatory compliance.

You will collaborate with cross-functional teams, including monitors, EDC vendors, and regulatory specialists, and contribute from data entry through database lock and closeout.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field.
• 4+ years of Clinical Data Management experience in CRO/pharma.
• Hands-on with EDC systems, preferably Medidata RAVE and Oracle Clinical.
• Experience in data review, query management, vendor reconciliation, and database lock.
• Knowledge of ICH-GCP, regulatory requirements, 21 CFR Part 11, and clinical trial processes.
• Strong communication, organization, and problem-solving skills.

Responsibilities

• Conduct comprehensive clinical data reviews using EDC systems to identify discrepancies.
• Manage data queries and coordinate with sites to ensure timely data corrections.
• Perform CRF freeze and lock activities and validate data before database lock.
• Reconcile vendor data with EDC data and source documents.
• Conduct UAT for EDC listings, screens, and edit checks.
• Maintain study documentation in eTMF and Veeva Vault to regulatory standards.
• Collaborate with cross-functional teams to support study execution and data quality.
• Communicate data quality issues clearly to stakeholders.

Skills

Clinical data review

Data management

EDC systems

Query management

Regulatory compliance

Communication

Organization

Problem-solving

Education

Bachelor's degree in Life Sciences/Pharmacy/Biotechnology/Clinical Research

Tools

Medidata RAVE

Oracle Clinical

Veeva Vault

eTMF

J-Review

Spotfire

Clinical Data Workbench

Job description

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About The Role

We are seeking a Clinical Data Management II to join our team in India on hybrid capacity. As a Clinical Data Management Associate, you will support clinical trial data review, data cleaning, and query management activities that advance new treatments for patients. This position plays a key role in ensuring data integrity, regulatory compliance, and clinical data accuracy. You'll collaborate with cross-functional teams including clinical monitors, EDC vendors, and regulatory specialists, follow industry-standard processes, and contribute to study operations from data entry through database lock and closeout.

Responsibilities include conducting comprehensive clinical data reviews, managing data discrepancies, performing CRF freeze and lock activities, and coordinating vendor data reconciliation, with opportunities to deepen your expertise in clinical data management and influence study outcomes.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through rigorous data stewardship, quality assurance, and cross-functional collaboration. With diverse teams and continuous learning opportunities, the Clinical Data Management Associate can explore career paths and expand skills across clinical research and data management.

Key Responsibilities

• Conduct comprehensive clinical data reviews using EDC systems and data review tools to identify discrepancies, missing data, and protocol deviations
• Manage data queries, track discrepancy resolution, and coordinate with clinical sites and internal stakeholders to ensure timely and accurate data corrections
• Perform CRF freeze and lock activities, including validation of data completeness and accuracy prior to database lock
• Reconcile vendor-supplied data, including local laboratory results and external data sources, ensuring alignment with EDC data and source documentation
• Conduct User Acceptance Testing (UAT) for EDC listings, screens, and edit checks to validate system functionality and data integrity
• Maintain comprehensive study documentation within eTMF and Veeva Vault systems, ensuring compliance with regulatory requirements and company standards
• Collaborate with cross-functional teams including clinical monitors, data managers, EDC vendors, and regulatory specialists to support study execution and data quality
• Communicate data quality issues, discrepancies, and resolutions clearly to stakeholders through written reports and team meetings

You’ll Thrive In This Role If You Bring

• Strengths in clinical data review, attention to detail, and problem-solving in complex data environments
• Hands-on experience with EDC systems, data review tools, and clinical data management processes
• The ability to collaborate across teams and communicate clearly with clinical sites, vendors, and internal stakeholders
• A patient-focused mindset, strong attention to detail, and commitment to data integrity and regulatory compliance
• Comfort working with EDC systems, data review platforms, eTMF documentation systems, and 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
• Hands-on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical
• Experience in data review, query management, vendor reconciliation, and database lock activities
• Knowledge of ICH-GCP, regulatory requirements, 21 CFR Part 11, and clinical trial processes
• Strong communication, organization, and problem-solving skills

Preferred Qualifications

• Experience with Veeva Vault and eTMF documentation systems
• Familiarity with data review tools such as J-Review or Spotfire
• Experience with Clinical Data Workbench or other advanced data analysis platforms
• Experience in specific therapeutic areas or study phases

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.