Data Surveillance Analyst

Role Overview

• Analyzing scientific and operational data to support the Data Surveillance process
• Reviewing project-specific Quality Tolerance Limits
• Assisting in developing Data Surveillance Plans (DSPs)
• Conducting defined project reviews
• Attending internal and external Data Surveillance meetings to present relevant findings
• Supporting cross-functional study team with expertise of Data Surveillance Process and supporting technologies
• Supporting the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits
• Configuring and maintaining Data Surveillance technologies
• Reviewing relevant data to identify findings related to trends, outliers, emerging risks, and systemic issues
• Documenting findings from Data Surveillance review
• Providing feedback and working with Technology teams to identify potential solutions
• Performing presentations explaining identified findings to internal cross-functional study team and client team
• Applying working knowledge and judgment to identify and evaluate potential data quality trends, outliers, and emergent issues
• Determining and implementing appropriate follow-up actions with guidance if applicable
• Actively participating in external or internal meetings and audits & regulatory inspections as required
• Recognizing impact of study non-compliance/issues/delays/data quality signals and communicating/escalating to FL any site and/or study issues that require immediate action
• Maintaining a working knowledge of and ensuring compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, and study
• Collaborating with DS Team Members to correlate findings from various sources
• Supporting Project Leads with DS Review meetings, driving reviews and decisions as needed and agreeing on actions
• Engaging DS Team to compile signals/actions into client ready list
• Completing, sharing, and filing Central Monitoring Report
• Supporting Data Surveillance close out activities

Requirements

• Min. 2 to 3 years of relevant medical, clinical or data management work experience
• Experience of working within an adaptive monitoring design study, and/or participating in a Central Monitoring/Data Surveillance process highly recommended
• Educated to a degree level (medical, biological science, pharmacy, and/or data analytics, preferred)
• Fluent English – spoken & written
• Familiarity with centralized monitoring and Data Driven Monitoring practices
• Proficient in data analysis, trend identification, and issue triage
• Knowledge of programming languages preferred
• Basic SAS programming and/or SQL script writing preferred
• Risks management and control, quality management and assurance experience preferred
• Client-focused with strong quality orientation
• Effective in matrix and global virtual team environments
• Excellent interpersonal and communication skills, including presentation skills
• Strong time management and multitasking capabilities
• Ability to work independently with minimal supervision

Tech Stack

• Google Cloud Platform
• SQL

Benefits

• Competitive financial packages
• Training and development
• Healthy work/life balance