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Data Surveillance Analyst

2.00 to 5.00 Years   Chennai   03 Mar, 2022
PAREXEL International
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    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. Key Accountabilities:Accountability Supporting ActivitiesRBQM/Department Support Participate in cross functional meetings Initiative participation Metrics reportingBusiness Development/Sponsor Support Data Surveillance Process Presentations DS technologies demonstrations DS Findings / CluePoints Analysis PresentationsTechnology Thorough knowledge of and adept at using Parexel DDM Tool, DS Application and CluePoints Central Monitoring PlatformStart-Up Act as PAREXEL s Data Surveillance Analysis expert Support 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.)Maintenance and Close Out Act as PAREXEL s Data Surveillance Analyst, assess and review available study data to identify data quality trends, outliers, lack of variability, breeches of Quality Tolerance Limits, and other risks to study data quality and overall integrity. Review relevant data via the Data Surveillance application, CluePoints, DDM Application, and/or other relevant reports and systems Document findings from Data Surveillance activities in the DS Findings & Actions Log, CluePoints Signals & Actions Tracker, and other systems as directed Participate in regular Data Surveillance meetings and communicate findings from various reviews to cross-functional leads on the project Work with Technology teams to identify potential solutions aligned with Parexel s business and technology strategy. Identify and evaluate potential data quality issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable. Actively participate 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. QualificationsSkills: 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 EnglishKnowledge and Experience: 2+ years of relevant statistical, health science, clinical, data management, or central monitoring experience, recommendedEducation: Educated to a degree level (statistical, medical, clinical/health science, data management/analytics),

Keyskills :
data qualitydata managementproblem solvingsas programmingtime managementmanagement skillsstatistical analysis

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