Data Surveillance Analyst
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Job Description
Data Surveillance Analyst responsible for data analysis and compliance with clinical monitoring at Parexel. Engaging in Data Surveillance Plans and documentation to advance clinical trial processes.
Responsibilities:
- Analyze scientific and operational data to support the Data Surveillance process
- Review project-specific Quality Tolerance Limits
- Assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews
- Attend internal and external Data Surveillance meetings, presenting relevant findings to the project team
- Document findings from Data Surveillance activities in the DS Findings Form
- Provide feedback and work with Technology teams to identify potential solutions
- Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines
- Collaborate with DS Team Members to correlate findings from various sources
- Support documentation of actions in Clue Points Issue Management system
- Complete, share, and file Central Monitoring Report
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
- 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
- Educated to a degree level (medical, biological science, pharmacy and/or data analytics, preferred) or relevant clinical, technology or business equivalent
Benefits:
- Employee health benefits
- Flexible work arrangements
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