Data Surveillance Analyst

🔥 0 minutes ago

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

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

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Analyst

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 set up standard and bespoke KRIs • Create and set up statistical analysis parameters • Review relevant data according to project-specific Data Surveillance Plans and Quality Tolerance Limits • Document findings in the DS Findings Form, 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, and determine appropriate follow-up actions • Participate in Investigator meetings, external and internal meetings, audits, and regulatory inspections as required • Communicate and promptly escalate site or 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 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 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

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