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The Data Surveillance Analyst (DSA) is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing project-specific Quality Tolerance Limits. They assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews. The DSA also attends internal and external Data Surveillance meetings, where they present relevant findings to the project team.
Job Responsibility
Analyzing scientific and operational data to support the Data Surveillance process and reviewing project-specific Quality Tolerance Limits
Developing Data Surveillance Plans (DSPs) and conducting defined project reviews
Attending internal and external Data Surveillance meetings, presenting relevant findings to the project team
Supporting cross-functional study team with expertise of Data Surveillance Process and supporting technologies
Configuring and Maintaining Data Surveillance technologies
Reviewing relevant data via the scoped technologies, identifying findings related to trends, outliers, emerging risks, and systemic issues
Documenting findings from Data Surveillance review
Providing feedback and working with Technology teams to identify potential solutions
Performing presentations explaining identified findings to internal cross-functional study team and client team
Applying working knowledge to identify and evaluate potential data quality trends, outliers, and emergent issues
Actively participating in external or internal meetings and audits & regulatory inspections
Recognizing impact of study non-compliance/issues/delays/data quality signals and communicating/promptly escalating to FL
Maintaining working knowledge of and ensuring compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other training requirements and study
Collaborating with DS Team Members to correlate findings from various sources
Supporting Project Leads with DS Review meeting
Engaging DS Team to compile signals/actions into client ready list
Completing, sharing, and filing Central Monitoring Report
Supporting 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.