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Parexel is hiring for the position of Data Surveillance Analyst (DSA) in India. This opportunity is suitable for professionals with experience in clinical research, medical data, data management, or related fields who are interested in Risk-Based Quality Management (RBQM), centralized monitoring, and data surveillance.
Job Details
- Company: Parexel
- Position: Data Surveillance Analyst
- Job ID: R0000042355
- Location: Serilingampalli, Telangana, India
- Work Mode: Remote
- Experience: 2+ years of relevant experience recommended
- Employment: Full-time
- Industry: Clinical Research / Life Sciences
About the Role
The Data Surveillance Analyst will support Parexel’s Data Surveillance processes by analyzing scientific and operational data, identifying data quality trends and outliers, and reviewing project-specific Quality Tolerance Limits (QTLs).
The role also involves supporting the development of Data Surveillance Plans (DSPs), configuring surveillance technologies, conducting project reviews, documenting findings, and participating in internal and external Data Surveillance meetings.
Key Responsibilities
Data Surveillance Plan & Technology
- Support the development of Data Surveillance Plans, including Key Risk Indicators (KRIs), Quality Tolerance Limits, and statistical analysis.
- Configure and maintain Data Surveillance technologies such as the Clue Points Central Monitoring Platform.
- Create data import mappings for different data sources.
- Set up standard and bespoke KRIs.
- Configure statistical analysis parameters.
Data Surveillance & Review
- Review project data according to the Data Surveillance Plan.
- Identify data quality trends, outliers, and emerging issues.
- Document findings in relevant tracking systems and DS Findings Forms.
- Perform core reviews and refresh surveillance technologies for each review cycle.
- Document atypical data and collaborate with team members to correlate findings from multiple sources.
- Support Data Surveillance review meetings and help drive actions and decisions.
- Assist in compiling signals and actions into client-ready reports.
- Support documentation of actions through the Clue Points Issue Management system.
- Complete, share, and file Central Monitoring Reports.
Compliance & Collaboration
- Participate in investigator meetings, internal/external meetings, audits, and regulatory inspections when required.
- Identify and escalate critical site or study issues.
- Collaborate with technology and Data Surveillance teams to develop appropriate solutions.
- Ensure compliance with ICH-GCP guidelines, applicable regulations, Parexel SOPs, and sponsor requirements.
- Work effectively with global and virtual teams while maintaining strong communication and quality standards.
Skills & Competencies
Candidates should have:
- Knowledge of RBQM processes and data surveillance methods.
- Familiarity with centralized monitoring and Data-Driven Monitoring.
- Strong data analysis and trend identification skills.
- Ability to perform issue triage and identify emerging data quality concerns.
- Basic understanding of SDTM domains and data operations.
- Basic SAS programming skills.
- Basic SQL scripting knowledge.
- Familiarity with CTMS, EDMS, and Microsoft Office.
- Strong communication and presentation skills.
- Good time management and multitasking abilities.
- Ability to work independently with minimal supervision.
- Strong client-focused and quality-oriented approach.
Experience Required
Parexel recommends 2 or more years of relevant experience in areas such as:
- Medical or clinical research
- Clinical data management
- Data analytics
- Centralized monitoring
- Data Surveillance
- Risk-Based Quality Management
Experience working on adaptive monitoring design studies or participating in a Central Monitoring/Data Surveillance process is highly desirable.
Educational Qualification
Candidates should have a degree-level qualification in one of the following areas:
- Pharmacy
- Medical Sciences
- Biological Sciences
- Data Analytics
- Clinical/Technology-related disciplines
- Business or another relevant equivalent qualification
Who Can Apply?
This opportunity can be particularly relevant for professionals from pharmacy, life sciences, clinical research, clinical data management, medical data, or data analytics backgrounds who have an interest in centralized monitoring and data-driven quality management.
How to Apply
Interested and eligible candidates can apply online through Parexel’s official careers platform for Data Surveillance Analyst – Job ID R0000042355.
Apply through the Parexel job posting and complete the application process as instructed.
Note: Candidates should review the official job description and eligibility requirements before applying. Job availability and requirements may change at the employer’s discretion.
