Data Surveillance Analyst

Role Overview: 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. You will assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews. Additionally, you will attend internal and external Data Surveillance meetings, where you will present relevant findings to the project team. Key Responsibilities: - Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis. - Configure and Maintain Data Surveillance technologies (e.g., Clue Points Central Monitoring Platform). - Create data import mapping for all data sources. - Create and set-up standard and bespoke Key Risk Indicators (KRIs). - Create and set-up statistical analysis parameters. - Review relevant data via the scoped technologies and additional sources as required to support reviews designated for the DS Analyst per the project specific Data Surveillance Plan, including project specific Quality Tolerance Limits. - Document findings from Data Surveillance activities in the DS Findings Form, Issue Tracking system(s) and other as appropriate. - Provide feedback and work with Technology teams to identify potential solutions that match the business and technology strategy. - 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 Investigator and other 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 positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the HPC values. - Work with team members to meet project goals and encourage the support of team members where required. - 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. - Refresh technologies for each review cycle per DS Plan. - Perform core reviews per DS Plan. - Document instances of atypical data per DS Plan. - Collaborate with DS Team Members to correlate findings from various sources. - Support PL 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. - Support documentation of actions in Clue Points Issue Management system (links to VV for any on-site interventions required). - Complete, share, and file Central Monitoring Report. - All other duties as assigned by management. Qualifications Required: - Comprehensive knowledge of Parexel RBQM processes and data surveillance methods. - Familiarity with centralized monitoring and Data Driven Monitoring practices. - Proficient in data analysis, trend identification, and issue triage. - Basic understanding of SDTM domains and data operations concepts. - Basic SAS programming skills. - Proficient in relevant software: CTMS, EDMS, MS Office, and Parexel-specific technologies. - Client-focused with strong quality orientation. - Effective in matrix and global virtual team environments. - Excellent interpersonal and communication skills, including presentation abilities. - Strong time management and multitasking capabilities. - Ability to work independently with minimal supervision. Additional Company Details: N/A Role Overview: 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. You will assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews. Additionally, you will attend internal and external Data Surveillance meetings, where you will present relevant findings to the project team. Key Responsibilities: - Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis. - Configure and Maintain Data Surveillance technologies (e.g., Clue Points Central Monitoring Platform). - Create data import mapping for all data sources. - Create and set-up standard and bespoke Key Risk Indicators (KRIs). - Create and set-up statistical analysis parameters. - Review relevant data via the scoped technologies and additional sources as required to support reviews designated for the DS Analyst per the project specific Data Surveillance Plan, including projec