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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
Apply working knowledge and judgment to identify and evaluate potential data quality trend, outliers, and emergent issues
Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable
Actively participate in external or internal meetings and audits & regulatory inspections as required
Recognize impact of study non-compliance/issues/delays/data quality signals and communicate/promptly escalate to FL any site and/or study issues that require immediate action
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
Requirements
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
Experience of working within an adaptive monitoring design study, and/or participating in a Central Monitoring/Data Surveillance process
Basic SAS programing or SQL or other programming languages with data analytics experience required
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
Client-focused with strong quality orientation
Excellent interpersonal and communication skills, including presentation skills
Strong time management and multitasking capabilities
Ability to work independently with minimal supervision