Data Surveillance Analyst

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

📋 Description

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

• Set up and maintain Data Surveillance technologies, such as the CluePoints Central Monitoring Platform.

• Develop data import mappings for all data sources.

• Create and configure both standard and custom KRIs and statistical analysis parameters.

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

• Document findings in DS Findings Forms, issue tracking systems, and other suitable platforms.

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

• Identify and assess data quality trends, outliers, and emerging issues.

• Determine and execute follow-up actions with relevant stakeholders.

• Participate in investigator, internal, external, audit, and regulatory inspection meetings.

• Escalate site or study issues that require immediate attention.

• Conduct core reviews and document atypical data as outlined in the Data Surveillance Plan.

• Work with DS Team Members to correlate findings from diverse sources.

• Assist Project Leads with Data Surveillance review meetings, evaluations, decisions, and actions.

• Compile signals and actions into client-ready lists.

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

• Complete, share, and archive Central Monitoring Reports.

⛳️ Requirements

• Bachelor's degree in medical science, biological science, pharmacy, and/or data analytics.

• Proficiency in English.

• Basic experience in SAS programming.

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

• Understanding of centralized monitoring and Data Driven Monitoring practices.

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

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

• Fundamental understanding of SDTM domains and data operations concepts.

• Experience with CluePoints is highly desirable.

• Client-oriented with a strong focus on quality.

• Effective in matrix and global virtual team settings.

• Exceptional interpersonal and communication skills, including presentation capabilities.

• Strong time management and multitasking skills.

• Ability to work autonomously with minimal supervision.

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

🏝️ Benefits

• Fully remote working arrangement.

• Opportunities for professional growth and development.

• Collaborative and inclusive workplace culture.

• Work-life balance.

• Flexible working hours.