Clinical Data Analyst I

Parexel; Hyderabad; Hybride; INR 700 000 - 1 000 000; Plein temps

Résumé du poste

Parexel, a leading global clinical development partner, is seeking a Clinical Data Analyst to join our Hyderabad team in a hybrid/onsite capacity. You will support clinical research activities, ensure data integrity, and contribute to study operations from planning through database lock.

You will collaborate with cross-functional teams, manage data review workflows, resolve data discrepancies, and ensure regulatory compliance using Veeva Vault, EDC systems, and data management tools.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related field.
• At least 2+ years of Clinical Data Management experience in CRO/pharma/biotech.
• Hands-on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical.
• Knowledge of ICH-GCP, regulatory requirements, and 21 CFR Part 11.

Responsabilités

• Conduct comprehensive clinical data reviews and data cleaning activities to ensure accuracy and regulatory compliance.
• Review clinical data listings and identify discrepancies and data quality issues requiring resolution.
• Manage query workflows, including generation, tracking, resolution, and documentation for database closure.
• Perform vendor data reconciliation activities and external data verification to ensure data integrity.
• Execute CRF freeze and lock activities in line with study timelines and regulatory standards.
• Conduct User Acceptance Testing (UAT) for data listings and system screens to validate functionality.
• Maintain study documentation within Veeva Vault and eTMF with proper version control.
• Collaborate with cross-functional stakeholders to resolve data issues and support milestones.
• Demonstrate proficiency with data workbench tools and EDC systems for data management.

Description du poste

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.

About The Role

We are seeking a Clinical Data Analyst (Data Manager, Clinical Operations Analyst) to join our team in a hybrid / on-site capacity. As a Clinical Data Analyst, you will support clinical research activities that advance new treatments for patients. This position plays a key role in study execution, data integrity oversight, regulatory compliance, and clinical data accuracy. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through database lock. Responsibilities include managing clinical data review workflows, resolving data discrepancies, and ensuring data quality through systematic query management and vendor reconciliation. With diverse teams and continuous learning opportunities, the Clinical Data Analyst can explore career paths and expand skills across clinical data management, regulatory affairs, and clinical operations.

Key Responsibilities

• Conduct comprehensive clinical data reviews and data cleaning activities to ensure accuracy, completeness, and compliance with study protocols and regulatory requirements
• Review clinical data listings and identify discrepancies, inconsistencies, and data quality issues requiring resolution
• Manage query workflows, including query generation, tracking, resolution, and documentation to support timely database closure
• Perform vendor data reconciliation activities, including local laboratory data review and external data verification to ensure data integrity
• Execute CRF freeze and lock activities in accordance with study timelines and regulatory standards, coordinating with clinical sites and internal teams
• Conduct User Acceptance Testing (UAT) for data listings, system screens, and edit checks to validate system functionality and data accuracy
• Maintain comprehensive study documentation within Veeva Vault and eTMF systems, ensuring proper organization, version control, and regulatory compliance
• Collaborate with cross-functional stakeholders including clinical monitors, programmers, biostatisticians, and regulatory teams to resolve data issues and support study milestones
• Demonstrate proficiency with clinical data workbench tools and EDC systems to support efficient data management and analysis

You’ll Thrive In This Role If You Bring

• Strong expertise in clinical data review, data cleaning, and query management processes
• Hands‑on experience with EDC systems and clinical data analysis tools in a fast‑paced environment
• Proficiency with Veeva Vault, eTMF documentation systems, and clinical data workbench platforms
• Experience working in clinical research, healthcare, or a regulated environment with attention to regulatory compliance
• The ability to collaborate across teams and communicate clearly with internal and external stakeholders
• A patient‑focused mindset and exceptional attention to detail in managing complex clinical datasets
• Comfort working with multiple software systems and a commitment to continuous learning

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific discipline
• Minimum 2+ 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
• Working knowledge of clinical research regulations, GCP guidelines, and clinical trial processes
• Knowledge of ICH‑GCP, regulatory requirements, and 21 CFR Part 11 compliance
• Strong communication, organization, and problem‑solving skills

Preferred Qualifications

• Experience with data review tools such as J-Review or Spotfire
• Proficiency with Microsoft Project and advanced PowerPoint presentations
• Experience in vendor reconciliation and database lock activities
• Familiarity with clinical trial data management best practices and quality assurance processes