Data Surveillance Analyst

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 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

• Support development of Data Surveillance Plans, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis • Configure and maintain Data Surveillance technologies, including the Clue Points 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 using scoped technologies and additional sources 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 • Participate in Investigator meetings, external and internal meetings, audits, and regulatory inspections as required • Recognize and escalate site or study issues requiring immediate action • Collaborate with team members to meet project goals and correlate findings from various sources • Support Data Surveillance review meetings, driving reviews and decisions as needed and agreeing on actions • Compile signals and actions into client-ready lists • Support documentation of actions in the Clue Points Issue Management system • Complete, share, and file Central Monitoring Reports • Refresh technologies for each review cycle, perform core reviews, and document atypical data per the Data Surveillance Plan • Perform other duties assigned by management

🎯 Requirements

• 2 or more years of relevant medical, clinical or data management work experience recommended • Experience of working within an adaptive monitoring design study, and/or participating in a Central Monitoring/Data Surveillance process highly recommended • Basic SAS programming and/or SQL script writing required • Educated to a degree level (medical, biological science, pharmacy and/or data analytics, preferred) or relevant clinical, technology or business equivalent • Comprehensive knowledge of Parexel RBQM processes and data surveillance methods • Familiarity with centralized monitoring and Data Driven Monitoring practices • Proficient in data analysis, trend identification, and issue triage • Basic understanding of SDTM domains and data operations concepts • Proficient in relevant software: CTMS, EDMS, MS Office, and Parexel-specific technologies • 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 • Knowledge of applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study