Data Surveillance Analyst

🕒 August 4

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

🇿🇦 South Africa – Remote 🇷🇴 Romania – 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

• Analyze scientific and operational data to support the Data Surveillance process • Review project-specific Quality Tolerance Limits • 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 through scoped technologies and additional sources according to project-specific plans • Document findings in DS Findings Forms, issue-tracking systems, and other appropriate records • Identify potential solutions with Technology teams aligned to 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, external, and internal meetings, audits, and regulatory inspections • Escalate study, site, compliance, delay, and data-quality issues requiring immediate action • Perform core reviews and document atypical data according to the Data Surveillance Plan • Collaborate with DS Team Members to correlate findings from multiple sources • Support Project Leads in Data Surveillance review meetings and drive reviews and decisions as needed • Compile signals and actions into client-ready lists • Document actions in the CluePoints Issue Management system • Complete, share, and file Central Monitoring Reports

🎯 Requirements

• University degree in medical, biological science, pharmacy, and/or data analytics • Fluent English • Basic SAS programming experience • Experience with Risk-Based Quality Management 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 • Ability to work effectively 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

• Professional growth and development opportunities • Work-life balance • Flexible working hours • Collaborative and inclusive work environment • Opportunity to participate in groundbreaking industry projects