Data Surveillance Analyst

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.

• Support the development of a robust Data Surveillance Plan, including Key Risk Indicators (KRIs), Quality Tolerance Limits, and central statistical analysis.
• Configure and Maintain Data Surveillance technologies (e.g., Clue Points 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.
• Maintain a positive, results orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the HPC values.
• Work with team members to meet project goals and encourage the support of team members where required.
• 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.