Data Surveillance Analyst

This is a fully remote position, open to applicants in South Africa, +2 more countries.

📋 Description

• Assist in the formulation of Data Surveillance Plans, which encompass Key Risk Indicators, Quality Tolerance Limits, and comprehensive statistical analysis.

• Set up and manage Data Surveillance technologies, including the CluePoints Central Monitoring Platform.

• Develop data import mappings for all data sources.

• Establish both standard and customized Key Risk Indicators (KRIs).

• Define and implement statistical analysis parameters.

• Assess relevant data in accordance with project-specific Data Surveillance Plans and Quality Tolerance Limits.

• Record findings in the DS Findings Form, issue-tracking systems, and other relevant platforms.

• Collaborate with Technology teams to pinpoint solutions that align with business and technology strategies.

• Recognize and assess data-quality trends, anomalies, and emerging issues, and decide on suitable follow-up actions.

• Engage in Investigator meetings, as well as external and internal discussions, audits, and regulatory inspections as necessary.

• Communicate and quickly escalate site or study issues that demand immediate attention.

• Conduct core reviews and document any atypical data as per the Data Surveillance Plan.

• Work alongside Data Surveillance Team Members to integrate findings from multiple sources.

• Assist Project Leads in Data Surveillance review meetings, assessments, decisions, and actions.

• Compile signals and actions into client-ready lists.

• Aid in documenting actions within the CluePoints Issue Management system.

• Complete, distribute, and file Central Monitoring Reports.

⛳️ Requirements

• A university degree in medical, biological sciences, pharmacy, and/or data analytics.

• Proficiency in English.

• Basic experience in SAS or R programming is required.

• Familiarity with Risk-Based Quality Management (RBQM) processes and data surveillance techniques.

• Knowledge of centralized monitoring and Data Driven Monitoring practices.

• Skilled in data analysis, trend recognition, and issue triage.

• Proficient in CTMS, EDMS, and MS Office applications.

• Basic understanding of SDTM domains and data operations concepts.

• Experience with CluePoints is a significant advantage.

• Client-focused with a strong commitment to quality.

• Effective in matrix and global virtual team settings.

• Excellent interpersonal and communication skills, including presentation capabilities.

• Strong time management and multitasking skills.

• Ability to work independently with minimal oversight.

• Must currently reside in and be legally authorized to work in South Africa, Serbia, or Romania.

🏝️ Benefits

• Opportunities for professional growth and development.

• Balanced work-life integration.

• Flexible working hours.