Data Surveillance Analyst

This is a fully remote position, open to applicants in Romania, +4 more countries.

📋 Description

• Analyze scientific and operational data to facilitate the Data Surveillance process.

• Review Quality Tolerance Limits specific to projects.

• Assist in the creation of Data Surveillance Plans (DSPs).

• Conduct defined reviews for specific projects.

• Attend both internal and external Data Surveillance meetings, presenting relevant findings to the project team.

• Aid in the development of Data Surveillance Plans, which include Key Risk Indicators, Quality Tolerance Limits, and central statistical analyses.

• Configure and maintain Data Surveillance technologies, including the creation of data import mappings, KRIs, and parameters for statistical analysis.

• Analyze relevant data using specified technologies and additional sources according to project-specific plans.

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

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

• Identify and assess data quality trends, outliers, and emerging issues; determine and implement necessary follow-up actions.

• Participate in investigator meetings, and both external and internal meetings, audits, and regulatory inspections as needed.

• Escalate site and study issues that require immediate attention.

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

• Work together with Data Surveillance Team Members to correlate findings from various sources.

• Support Project Leads in Data Surveillance review meetings, including reviews, decisions, and actions.

• Compile signals and actions into lists that are ready for client presentation.

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

• Complete, share, and archive Central Monitoring Reports.

⛳️ Requirements

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

• Proficient in English.

• Practical programming experience in SAS, R, and/or SQL is essential.

• 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 identification, and issue triage.

• Proficient in relevant software such as CTMS, EDMS, and MS Office.

• Basic understanding of SDTM domains and data operations concepts.

• Experience with CluePoints is highly advantageous.

• Client-oriented with a strong focus on quality.

• Effective in matrix and global virtual team environments.

• Excellent interpersonal and communication skills, including the ability to present effectively.

• Strong time management and multitasking skills.

• Capability to work independently with minimal supervision.

• Applicants must reside in one of the eligible locations.

🏝️ Benefits

• Opportunities for professional growth and development.

• Emphasis on work-life balance.

• Flexible working hours.