Data Surveillance Analyst - based in selected EMEA locations

Summary

Parexel is a global organization providing clinical research and related services. The Data Surveillance Analyst analyzes scientific and operational data, supports Data Surveillance Plan development, configures surveillance technologies, and conducts project-specific reviews. The role also documents findings, collaborates with project and technology teams, participates in meetings and audits, and escalates study issues when necessary.

Responsibilities

• Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis
• Configure and Maintain Data Surveillance technologies (e.g., CluePoints Central Monitoring Platform):
• Create data import mapping for all data sources
• Create and set-up standard and bespoke KRIs
• Create and set-up statistical analysis parameters
• Review relevant data via the scoped technologies and additional sources as required to support reviews designated for the DS Analyst per the project specific Data Surveillance Plan, including project specific Quality Tolerance Limits
• Document findings from Data Surveillance activities in the DS Findings Form, Issue Tracking system(s) and other as appropriate
• Provide feedback and work with Technology teams to identify potential solutions that match the business and technology strategy
• Apply working knowledge and judgment to identify and evaluate potential data quality trend, outliers and emergent issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable
• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required
• Recognize impact of study non-compliance/issues/delays/data quality signals and communicate/ promptly escalate to FL any site and/or study issues that require immediate action
• Perform core reviews per DS Plan
• Document instances of atypical data per DS Plan
• Collaborate with DS Team Members to correlate findings from various sources
• Support Project Leads with DS Review meeting, driving reviews and decisions as needed and agreeing on actions
• Engage DS Team to compile signals/actions into client ready list
• Support documentation of actions in CluePoints Issue Management system (links to IH for any on-site interventions required)
• Complete, share, and file Central Monitoring Report

Skills

• Applicants must be based in one of the eligible locations
• University degree (medical, biological science, pharmacy, and/or data analytics)
• Fluent English
• Hands-on programming experience in SAS, R, and/or SQL is a must-have
• 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 relevant software: CTMS, EDMS, MS Office
• Basic understanding of SDTM domains and data operations concepts
• 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
• Experience with CluePoints would be a strong asset

Qualifications

Must Haves

• Applicants must be based in one of the eligible locations
• University degree (medical, biological science, pharmacy, and/or data analytics)
• Fluent English
• Hands-on programming experience in SAS, R, and/or SQL is a must-have
• 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 relevant software: CTMS, EDMS, MS Office
• Basic understanding of SDTM domains and data operations concepts
• 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

Nice to Haves

• Experience with CluePoints would be a strong asset

Benefits

• Home-based position available to candidates in selected EMEA locations
• Collaborative and inclusive work environment
• Professional growth and development opportunities
• Work-life balance
• Flexible working hours