Data Surveillance Analyst

🕒 September 12

🌐 Romania, South Africa, +3 more countries – Remote

🇷🇴 Romania – Remote 🇿🇦 South Africa – Remote 🇵🇱 Poland – Remote 🇱🇹 Lithuania – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Analyst

👻 Ghost score 25%

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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

• Analyze scientific and operational data to support the 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 and present relevant findings to the project team • Support development of Data Surveillance Plans, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis • Configure and maintain Data Surveillance technologies, including creating data import mappings, KRIs, and statistical analysis parameters • Review relevant data using scoped technologies and additional sources according to project-specific plans • Document findings in DS Findings Forms, issue tracking systems, and other appropriate systems • Work with Technology teams to identify solutions aligned with business and technology strategy • Identify and evaluate data quality trends, outliers, and emergent issues; determine and implement follow-up actions • Participate in investigator meetings, external and internal meetings, audits, and regulatory inspections as required • Escalate site and study issues requiring immediate action • Perform core reviews and document atypical data per the Data Surveillance Plan • Collaborate with Data Surveillance Team Members to correlate findings from various sources • Support Project Leads with Data Surveillance review meetings, reviews, decisions, and actions • Compile signals and actions into client-ready lists • Support documentation of actions in the CluePoints Issue Management system • Complete, share, and file Central Monitoring Reports

🎯 Requirements

• University degree (medical, biological science, pharmacy, and/or data analytics) • Fluent English • Hands-on programming experience in SAS, R, and/or SQL is a must-have • 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 • Proficient in relevant software: CTMS, EDMS, MS Office • Basic understanding of SDTM domains and data operations concepts • Experience with CluePoints would be a strong asset • 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 • Applicants must be based in one of the eligible locations

🏖️ Benefits

• Professional growth and development opportunities • Work-life balance • Flexible working hours

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