Senior Clinical Data Analyst

🔥 42 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

📉 Data Analyst

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Support the Data Management Lead in study planning, execution, and project management activities • Draft EDC build timelines and perform database and edit check specification activities • Conduct user acceptance testing (UAT) for database, coding, site payment, and safety integrations • Create and maintain study documents and ensure proper filing in the electronic Trial Master File (eTMF) per study requirements • Coordinate data review activities, manage vendor deliverables, and support Data Quality Review meetings • Manage post-production activities, data migration, and database lock to ensure regulatory compliance and study timelines • Provide training and mentoring to junior Clinical Data Management staff and support cross-functional study teams • Contribute to study operations from planning through closeout • Support patient safety oversight, regulatory compliance, and clinical data accuracy

🎯 Requirements

• 8 or more years of end-to-end clinical data management experience from protocol review through database lock • Hands-on experience with Medidata RAVE and Oracle Clinical EDC systems • Knowledge of ICH-GCP, FDA guidelines, and clinical trial processes • Demonstrated expertise authoring and reviewing data management documents (DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines) • Strong communication, organization, and problem-solving skills • Experience in clinical research, healthcare, or a regulated environment • Expertise in protocol review, CRF/eCRF design, and database lock • Advanced proficiency with EDC systems, particularly Medidata RAVE and Oracle Clinical • Strong skills in data review, query management, query trend analysis, and data quality oversight • Comfort working with electronic data capture systems, eTMF platforms, and clinical trial management tools • Experience overseeing CRO or CDM vendors and managing study deliverables within timelines • Experience supporting audits, inspections, and regulatory submissions • Project management and metrics reporting experience in clinical research environments • Mentoring and leadership experience with junior data management staff

🏖️ Benefits

• Flexibility in work arrangements • Growth and continuous learning opportunities • Career path exploration across clinical research and data management • Training and mentoring opportunities • Diverse team environment

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