Clinical Data Analyst III

Job not on LinkedIn

đŸ”„ 13 hours ago

🇼🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

📉 Data Analyst

đŸ‘» Ghost score 10%

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Logo of Parexel

Parexel

10,000+ employees

Founded 1983

đŸ’Œ Consulting

đŸ„ 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

‱ Independently perform and lead clinical data validation, cleaning, review, and reconciliation activities throughout study conduct and database lock. ‱ Manage data queries and conduct manual and SAS-generated listing reviews. ‱ Reconcile external vendor data and ensure data integrity across systems. ‱ Identify project risks, highlight delivery concerns, and support mitigation planning. ‱ Prepare and maintain Data Management documentation and Trial Master File records. ‱ Lead User Acceptance Testing activities for clinical database setups. ‱ Review study protocols, EDC screens, and database configurations. ‱ Provide input into data management timelines and coordinate operational activities during study start-up. ‱ Track and review CRFs and support data entry activities as required. ‱ Perform quality control reviews and ensure compliance with SOPs, ICH-GCP guidelines, and regulatory requirements. ‱ Mentor and provide on-the-job training to Clinical Data Analysts. ‱ Serve as a Subject Matter Expert for data management tools, systems, and processes. ‱ Support continuous improvement initiatives and implementation of project-specific tools and efficiencies. ‱ Provide operational metric analysis and support scope change assessments and resource planning. ‱ Act as backup to the Data Management Lead when required.

🎯 Requirements

‱ Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related healthcare discipline. ‱ Relevant experience in Clinical Data Management within the clinical research or CRO industry. ‱ Demonstrated experience leading data management activities across clinical studies. ‱ Strong experience with Clinical Data Management Systems such as Medidata Rave, Oracle InForm, Veeva, DataLabs, or ClinBase. ‱ Advanced understanding of clinical data management processes, including data cleaning, reconciliation, and database lock activities. ‱ Expertise in database setup activities and data validation specifications. ‱ Knowledge of MedDRA and WHODrug coding dictionaries. ‱ Understanding of CDISC standards. ‱ Basic knowledge of SAS and programmed listings. ‱ Strong knowledge of ICH-GCP guidelines, clinical research regulations, and industry best practices. ‱ Experience leading virtual data management teams across global studies. ‱ Strong leadership, collaboration, stakeholder management, negotiation, influencing, problem-solving, root cause analysis, organizational, communication, presentation, mentoring, and coaching skills. ‱ Ability to independently interact with sponsors and stakeholders regarding data issues and study requirements. ‱ Adaptability to dynamic, fast-paced environments.

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