Clinical Data Analyst II

🔥 1 minute ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

📉 Data Analyst

👻 Ghost score 10%

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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

• Perform clinical data validation by extracting, cleaning, validating, and reconciling clinical trial data from various sources • Manage data queries and support database lock activities • Review manual and system-generated data listings to identify discrepancies and ensure data quality • Identify and resolve data inconsistencies • Support preparation and maintenance of Data Management documents and study-related records • Conduct User Acceptance Testing (UAT) for clinical database setups • Review study protocols, CRFs, and EDC screens when required • Track CRFs and support data entry activities as needed • Ensure adherence to SOPs, regulatory requirements, and ICH-GCP guidelines • Collaborate with cross-functional study teams and client stakeholders • Mentor junior data analysts and contribute to process improvement initiatives • Support study start-up activities

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline • Relevant experience in Clinical Data Management or the Clinical Research industry • Strong analytical and problem-solving abilities • Excellent attention to detail and commitment to quality • Strong verbal and written communication skills • Effective time management and prioritization skills • Ability to collaborate within cross-functional teams • Adaptability and willingness to learn new technologies and processes • Experience with Clinical Data Management Systems such as Medidata Rave, Veeva, DataLabs, ClinBase or others • Understanding of clinical data management processes, including data cleaning and database lock activities • Knowledge of MedDRA and WHODrug coding dictionaries • Basic knowledge of SAS and CDISC standards • Good understanding of ICH-GCP guidelines and clinical research regulations