Data Surveillance Analyst

This is a fully remote position, open to applicants in South Africa.

📋 Description

• The Data Surveillance Analyst (DSA) plays a key role in examining scientific and operational data to facilitate the Data Surveillance process and assess project-specific Quality Tolerance Limits.

• Assist in formulating Data Surveillance Plans (DSPs) and carry out specified project evaluations.

• Participate in both internal and external Data Surveillance meetings, sharing pertinent findings with the project team.

• Aid in the creation of a comprehensive Data Surveillance Plan, encompassing Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis.

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

• Analyze relevant data using the designated technologies and other necessary sources.

• Record outcomes from Data Surveillance activities in the DS Findings Form, Issue Tracking systems, and other appropriate documentation.

• Utilize practical knowledge and judgment to discern and assess potential data quality trends, outliers, and emerging issues.

• Actively engage in Investigator and other internal or external meetings and audits & regulatory inspections as required.

• Conduct core evaluations as per the DS Plan.

• Work collaboratively with DS Team Members to integrate findings from multiple sources.

• Assist Project Leads during DS Review meetings, facilitating reviews and decisions as necessary and agreeing on actions.

⛳️ Requirements

• A university degree in medical, biological science, pharmacy, and/or data analytics is preferred.

• Proficiency in English is essential.

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

• Basic knowledge of SAS programming, SQL, or other programming languages is required.

• Familiarity with centralized monitoring and Data Driven Monitoring practices.

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

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

• Fundamental understanding of SDTM domains and data operations concepts.

• Client-oriented with a strong emphasis 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 independently with minimal oversight.

🏝️ Benefits

• Competitive financial packages.

• Opportunities for training and development.

• Emphasis on health and wellness.