Data Surveillance Analyst

This is a fully remote position, open to applicants in India.

📋 Description

• Assist in the creation of Data Surveillance Plans, which include Key Risk Indicators, Quality Tolerance Limits, and comprehensive statistical analysis.

• Configure and oversee Data Surveillance technologies, such as the Clue Points Central Monitoring Platform.

• Develop data import mappings for all data sources.

• Establish and implement both standard and customized KRIs.

• Define and set statistical analysis parameters.

• Analyze relevant data utilizing scoped technologies and additional resources as per project-specific Data Surveillance Plans and Quality Tolerance Limits.

• Document findings in DS Findings Forms, issue-tracking systems, and other suitable platforms.

• Collaborate with Technology teams to identify solutions that align with business objectives and technology strategies.

• Detect and assess data quality trends, outliers, and emerging issues; formulate and execute follow-up actions.

• Engage in Investigator meetings, as well as external and internal discussions, audits, and regulatory inspections as necessary.

• Identify and escalate site or study issues that require urgent attention.

• Work alongside team members to achieve project objectives and correlate findings from diverse sources.

• Facilitate Data Surveillance review meetings, guiding reviews and decisions as necessary while agreeing on subsequent actions.

• Compile signals and actions into client-ready documentation.

• Assist in documenting actions within the Clue Points Issue Management system.

• Complete, distribute, and archive Central Monitoring Reports.

• Refresh technologies for each review cycle, conduct core reviews, and document atypical data according to the Data Surveillance Plan.

• Carry out additional tasks as assigned by management.

⛳️ Requirements

• A minimum of 2 years of relevant experience in medical, clinical, or data management is recommended.

• Experience in adaptive monitoring design studies, and/or involvement in a Central Monitoring/Data Surveillance process is highly recommended.

• Basic proficiency in SAS programming and/or SQL script writing is required.

• A degree in a relevant field (medical, biological science, pharmacy, and/or data analytics preferred) or equivalent clinical, technology, or business education is necessary.

• In-depth knowledge of Parexel RBQM processes and data surveillance methodologies.

• Familiarity with centralized monitoring and Data Driven Monitoring practices.

• Skilled in data analysis, trend identification, and issue triage.

• Basic understanding of SDTM domains and data operations concepts.

• Proficient in relevant software including CTMS, EDMS, MS Office, and Parexel-specific technologies.

• Client-oriented with a strong focus on quality.

• Effective in matrix and global virtual team settings.

• Exceptional interpersonal and communication skills, including presentation capabilities.

• Strong time management and multitasking skills.

• Ability to work independently with minimal supervision.

• Knowledge of applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, and other relevant training requirements and studies.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Collaborative and inclusive work environment.

• Competitive salary and performance-based incentives.