Data Surveillance Analyst - based in South Africa, Poland, Romania, Lithuania

Summary

Parexel is a multinational organization focused on providing high-quality data surveillance and analysis. The Data Surveillance Analyst will analyze scientific and operational data to support the Data Surveillance process and develop Data Surveillance Plans, while also participating in meetings and presenting findings to the project team.

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

• Fluent English
• Experience with Risk-Based Quality Management (RBQM) processes and data surveillance methods
• Basic SAS programming or SQL or other programming languages required
• 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
• Excellent interpersonal and communication skills, including presentation abilities
• Ability to work independently with minimal supervision
• University degree (medical, biological science, pharmacy, and/or data analytics, preferred)
• Familiarity with centralized monitoring and Data Driven Monitoring practices
• Client-focused with strong quality orientation
• Effective in matrix and global virtual team environments
• Strong time management and multitasking capabilities

Qualifications

Must Haves

• Fluent English
• Experience with Risk-Based Quality Management (RBQM) processes and data surveillance methods
• Basic SAS programming or SQL or other programming languages required
• 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
• Excellent interpersonal and communication skills, including presentation abilities
• Ability to work independently with minimal supervision

Nice to Haves

• University degree (medical, biological science, pharmacy, and/or data analytics, preferred)
• Familiarity with centralized monitoring and Data Driven Monitoring practices
• Client-focused with strong quality orientation
• Effective in matrix and global virtual team environments
• Strong time management and multitasking capabilities

Benefits

• Fully home-based working is available in all four locations.
• We offer competitive financial packages, training, and development.
• Smooth induction and training program.
• Exciting professional challenges but with a healthy work/life balance.
• We value your welfare just as highly as that of our patients.