Data Surveillance Analyst

🔥 0 minutes ago

🌐 Romania, South Africa, +1 more countries – Remote

🇷🇴 Romania – Remote 🇿🇦 South Africa – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 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 development of Data Surveillance Plans, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis • Configure and maintain Data Surveillance technologies, including CluePoints Central Monitoring Platform • Create data import mappings for all data sources • Create and configure standard and bespoke KRIs and statistical analysis parameters • Review relevant data according to project-specific Data Surveillance Plans and Quality Tolerance Limits • 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 with relevant parties • Participate in investigator, internal, external, audit, and regulatory inspection meetings • Escalate site or study issues requiring immediate action • Perform core reviews and document atypical data per the Data Surveillance Plan • Collaborate with DS 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 in medical science, biological science, pharmacy, and/or data analytics • Fluent English • Basic SAS programming experience • Experience with Risk-Based Quality Management (RBQM) processes and data surveillance methods • Familiarity with centralized monitoring and Data Driven Monitoring practices • Proficiency in data analysis, trend identification, and issue triage • Proficiency with CTMS, EDMS, and MS Office • Basic understanding of SDTM domains and data operations concepts • Experience with CluePoints is 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 • Must be currently based in and legally authorized to work in South Africa, Serbia, or Romania

🏖️ Benefits

• Fully home-based working • Professional growth and development opportunities • Collaborative and inclusive work environment • Work-life balance • Flexible working hours