Data Surveillance Analyst
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Job Description
Data Surveillance Analyst responsible for analyzing scientific data and developing surveillance plans at Parexel. Collaborating with teams to ensure quality in monitoring clinical trials while working in a remote environment.
Responsibilities:
- 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:
- 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 programing 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.
Benefits:
- Competitive financial packages
- Training and development
- Healthy work/life balance
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