Data Surveillance Analyst

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Analyze scientific and operational data to support Data Surveillance process • Review project-specific Quality Tolerance Limits • Assist in developing Data Surveillance Plans (DSPs) • Conduct defined project reviews • Attend internal and external Data Surveillance meetings, presenting relevant findings to the project team • Support the development of a robust Data Surveillance Plan • Configure and maintain Data Surveillance technologies (e.g., CluePoints Central Monitoring Platform) • Review relevant data to support reviews per the project specific Data Surveillance Plan • Document findings from Data Surveillance activities • Provide feedback and collaborate with technology teams • Identify potential data quality trend, outliers and emergent issues • Participate in Investigator and other external/internal meetings and audits & regulatory inspections • Recognize impact of study non-compliance/issues/delays/data quality signals and communicate promptly

🎯 Requirements

• University degree (medical, biological science, pharmacy, and/or data analytics, preferred) • Fluent English • Experience with Risk-Based Quality Management (RBQM) processes and data surveillance methods • Familiarity with centralized monitoring and Data Driven Monitoring practices • Proficient in data analysis, trend identification, and issue triage • Basic SAS programming or SQL or other programming languages with data analytics experience required • Proficient in relevant software: CTMS, EDMS, MS Office • Basic understanding of SDTM domains and data operations concepts • Client-focused with strong quality orientation • Effective in matrix and global virtual team environments • Excellent interpersonal and communication skills, including presentation abilities • Strong time management and multitasking capabilities • Ability to work independently with minimal supervision

🏖️ Benefits

• Competitive financial packages • Training and development • Healthy work/life balance