Data Surveillance Analyst
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Job Description
Data Surveillance Analyst supporting Parexel’s clinical development solutions through data surveillance, risk indicators, and central monitoring. Reviewing data quality signals and escalating study issues.
Responsibilities:
- 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
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