Parexel
India
Biotech & Pharmaceutical
The Data Surveillance Analyst (DSA) provides leadership and expertise in all aspects of Data Surveillance and the set-up of support technologies, managing the delivery of all relevant data surveillance activities from Data Surveillance plan development and analysis tools setup through final Data Surveillance review.
- Act as PAREXEL’s Data Surveillance Analysis expert
- Participates in cross functional meetings
- Presents Data Surveillance Process and technologies demonstrations
- Provides DS Findings / CluePoints Analysis Presentations
- Has a thorough knowledge of and adept at using Parexel Data Driven Monitoring Tool, DS Application and CluePoints Central Monitoring Platform
- Supports the development of a robust Data Surveillance Plan, Key Risk Indicators, Quality Tolerance Limits and Data Surveillance technologies (Parexel Data Surveillance, CluePoints Statistical Analysis Platform, etc.)
- Reviews relevant data via the Data Surveillance application, CluePoints, DDM Application, and/or other relevant reports and systems
- Documents findings from Data Surveillance activities in the DS Findings & Actions Log, CluePoints Signals & Actions Tracker, and other systems as directed
- Participates in regular Data Surveillance meetings and communicate findings from various reviews to cross-functional leads on the project
- Works with Technology teams to identify potential solutions aligned with Parexel’s business and technology strategy.
- Identifies and evaluates potential data quality issues. Determines and implements appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable.
- Actively participates external or internal meetings and audits & regulatory inspections as required.
- Recognizes 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.
Qualifications
Skills:
- Excellent analytical and problem-solving skills
- Understand data structure, (SDTM) data mapping
- Understand fundamentals of statistical data analysis
- Basic SAS programming, preferred
- Strong oral and written communication skills
- Strong presentation skills
- Self-directed and ability to work independently in a virtual team environment
- Strong time management skills, with ability to effectively prioritize and manage multi-project workload
- Fluent in written and oral English
Knowledge and Experience:
- 2+ years of relevant statistical, health science, clinical, data management, or central monitoring experience, recommended
Education:
- Educated to a degree level (statistical, medical, clinical/health science, data management/analytics)
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