Data Surveillance Analyst

🔥 0 minutes ago

🌐 South Africa, Lithuania, +2 more countries – Remote

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

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 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

• Analyze scientific and operational data to support the Data Surveillance process • Review project-specific Quality Tolerance Limits • Assist in developing Data Surveillance Plans, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis • Configure and maintain Data Surveillance technologies such as CluePoints Central Monitoring Platform • Create data import mappings for all data sources • Create and set up standard and bespoke KRIs and statistical analysis parameters • Review relevant data and conduct project-specific reviews per the Data Surveillance Plan • Document findings in the DS Findings Form, Issue Tracking systems, and other appropriate systems • Work with Technology teams to identify solutions matching business and technology strategy • Identify and evaluate data quality trends, outliers, and emergent issues, and implement follow-up actions • Participate in investigator meetings, internal and external meetings, audits, and regulatory inspections • Escalate site or study issues requiring immediate action to FL • Perform core reviews and document atypical data per the DS 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 CluePoints Issue Management system • Complete, share, and file Central Monitoring Reports

🎯 Requirements

• University degree (medical, biological science, pharmacy, and/or data analytics) • Fluent English • Basic SAS or R programming experience required • 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 CTMS, EDMS, and 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 • Must be currently based in and legally authorized to work in South Africa, Lithuania, Serbia, or Romania

🏖️ Benefits

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