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

📋 Description

• • Support cross-functional study teams by providing expert knowledge of the Data Surveillance Process and associated technologies.
• • Contribute to the development of robust Data Surveillance Plans (DSPs), including identification and definition of Key Risk Indicators and Quality Tolerance Limits.
• • Configure, maintain, and optimize Data Surveillance technologies to ensure accurate and efficient data monitoring.
• • Review clinical and operational data through scoped technologies to identify trends, outliers, emerging risks, and systemic data quality issues.
• • Document all findings from Data Surveillance reviews with clarity and precision for internal and client-facing purposes.
• • Present analytical findings and risk signals to internal cross-functional teams and external client teams during Data Surveillance meetings.
• • Apply clinical and data judgment to evaluate potential data quality issues and determine appropriate follow-up actions in collaboration with relevant stakeholders.
• • Actively participate in internal and external audits, regulatory inspections, and quality reviews as required by project or regulatory needs.
• • Recognize and promptly escalate any site or study issues that indicate non-compliance, delays, or critical data quality signals to functional leads.
• • Ensure full compliance with ICH-GCP guidelines, international and local regulations, Parexel SOPs, and sponsor-specific training requirements.
• • Collaborate with Data Surveillance team members to correlate findings across multiple data sources and ensure consolidated insights.
• • Support Project Leads in driving Data Surveillance review meetings, facilitating decisions, and agreeing on actionable outcomes.
• • Compile risk signals and corrective actions into client-ready reports and documentation.
• • Complete, share, and file Central Monitoring Reports in accordance with project timelines and regulatory standards.
• • Support the close-out activities of Data Surveillance processes, ensuring all documentation is accurate, complete, and archived appropriately.
• • Maintain a strong focus on data quality, risk management, and quality assurance throughout all phases of study monitoring.
• • Work effectively within a global, matrixed, and virtual team environment with minimal supervision.
• • Demonstrate excellent time management and multitasking abilities to handle multiple study obligations concurrently.
• • Utilize strong interpersonal and communication skills to influence outcomes, clarify complex data findings, and build collaborative relationships across teams.
• • Deliver presentations with clarity and confidence to diverse audiences, including clinical, statistical, and regulatory stakeholders.