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The Data Surveillance Analyst (DSA) is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing project-specific Quality Tolerance Limits. They assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews. The DSA also attends internal and external Data Surveillance meetings, where they present relevant findings to the project team.
Job Responsibility:
Support cross-functional study team with expertise of Data Surveillance Process and supporting technologies
Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits
Configure and Maintain Data Surveillance technologies (e.g., Clue Points Central Monitoring Platform)
Review relevant data via the scoped technologies, identifying findings related to trends, outliers, emerging risks, and systemic issues
Document findings from Data Surveillance review
Provide feedback and work with Technology teams to identify potential solutions that match the business and technology strategy
Perform presentations explaining identified findings to internal cross-functional study team and client team
Apply working knowledge and judgment to identify and evaluate potential data quality trend, outliers, and emergent issues
Actively participate in 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
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study
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 Clue Points Issue Management system
Complete, share, and file Central Monitoring Report
Support Data Surveillance close out activities
Requirements:
Min. 2 to 3 years of relevant medical, clinical or data management work experience
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
Experience with CluePoints system required
Educated to a degree level (medical, biological science, pharmacy, and/or data analytics, preferred)
Fluent English – spoken & written
Familiarity with centralized monitoring and Data Driven Monitoring practices
Proficient in data analysis, trend identification, and issue triage
Knowledge of programing languages highly recommended
Risks management and control, quality management and assurance experience preferred
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
What we offer:
Competitive financial packages, training, and development
Healthy work/life balance
Fully flexible work arrangement - you can be fully home based
Office desk available if you live close to our office