Support cross-functional study team with expertise of Data Surveillance Process and supporting technologies
Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits
Configure and Maintain Data Surveillance technologies
Review relevant data via the scoped technologies, identifying findings related to trends, outliers, emerging risks, and systemic issues
Document findings from Data Surveillance review
Provide feedback and work with Technology teams to identify potential solutions that match the business and technology strategy
Perform presentations explaining identified findings to internal cross-functional study team and client team
Actively participate in external or internal meetings and audits & regulatory inspections as required
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study
Collaborate with DS Team Members to correlate findings from various sources
Support Project Leads with DS Review meeting, driving reviews and decisions as needed and agreeing on actions
Engage DS Team to compile signals/actions into client ready list
Complete, share, and file Central Monitoring Report
Support Data Surveillance close out activities

Educated to a degree level (medical, biological science, pharmacy, and/or data analytics, preferred)
Fluent English – spoken & written
Min. 3 years of relevant medical, clinical or data management work experience within CRO/Pharma
Knowledge of programming languages
Basic SAS programming and/or SQL script writing preferred
Experience of working within an adaptive monitoring design study, and/or participating in a Central Monitoring/Data Surveillance process highly recommended
Familiarity with centralized monitoring and Data Driven Monitoring practices
Proficient in data analysis, trend identification, and issue triage
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.

Data Surveillance Analyst

Key skills