India's DMPLOI - Jobs & Networking App
Parexel Hiring: Data Surveillance Analyst – Remote Job in India
Parexel is hiring a Data Surveillance Analyst for its Clinical Trials team. This is a remote opportunity in India for professionals with experience in clinical data, medical, pharmacy, or data management and an interest in Risk-Based Quality Management (RBQM), centralized monitoring, and data surveillance.
Job Details
| Position | Data Surveillance Analyst |
|---|---|
| Company | Parexel |
| Job ID | R0000042355 |
| Location | India – Remote |
| Category | Clinical Trials |
| Work Type | Remote |
| Experience | 2+ years of relevant experience recommended |
| Qualification | Degree in Medical, Biological Science, Pharmacy, Data Analytics, or related field |
About the Role
The Data Surveillance Analyst will analyze scientific and operational data to support the Data Surveillance process and review project-specific Quality Tolerance Limits (QTLs).
The role involves supporting Data Surveillance Plan development, configuring data surveillance technologies, conducting project reviews, identifying data quality trends and outliers, documenting findings, and presenting relevant insights during internal and external project meetings.
Key Responsibilities
Data Surveillance Plan & Technology
- Support development of Data Surveillance Plans (DSPs).
- Assist with defining Key Risk Indicators (KRIs), Quality Tolerance Limits, and statistical analyses.
- 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 customized KRIs.
- Configure statistical analysis parameters.
- Refresh technologies for each review cycle according to the Data Surveillance Plan.
Data Surveillance Reviews
- Review project data using designated surveillance technologies and other relevant data sources.
- Perform core reviews according to the Data Surveillance Plan.
- Identify atypical data, trends, outliers, and emerging data quality issues.
- Document findings in the appropriate findings and issue-tracking systems.
- Collaborate with Data Surveillance team members to correlate findings from multiple sources.
- Support the Project Lead during Data Surveillance review meetings.
- Help identify signals and agree on appropriate follow-up actions.
- Support documentation of actions in the Clue Points Issue Management system.
- Complete, share, and file Central Monitoring Reports.
Compliance & Collaboration
- Escalate significant site or study issues requiring immediate attention.
- Participate in investigator meetings, internal/external meetings, audits, and regulatory inspections as required.
- Maintain compliance with ICH-GCP, applicable international and local regulations, Parexel SOPs, sponsor requirements, and study-specific procedures.
- Work effectively with global, cross-functional, and virtual teams.
- Build strong collaborative relationships with project and technology teams.
Skills Required
Candidates should have:
- Knowledge of RBQM processes and data surveillance methodologies.
- Understanding of centralized monitoring and Data-Driven Monitoring.
- Strong data analysis and trend-identification skills.
- Ability to identify and triage data quality issues.
- Basic understanding of SDTM domains and data operations.
- Basic SAS programming skills.
- Basic SAS and/or SQL script writing experience.
- Familiarity with CTMS, EDMS, and Microsoft Office.
- Strong communication and presentation skills.
- Excellent interpersonal and collaboration abilities.
- Strong time management and multitasking skills.
- Ability to work independently with minimal supervision.
- Strong quality orientation and client-focused approach.
Experience
- 2 or more years of relevant experience in medical, clinical, or data management work is recommended.
- Experience with adaptive monitoring design studies is highly desirable.
- Experience participating in Central Monitoring or Data Surveillance processes is highly recommended.
- Basic SAS programming and/or SQL scripting experience is required.
Educational Qualification
Candidates should have a degree in one of the following areas:
- Medical Sciences
- Biological Sciences
- Pharmacy
- Data Analytics
- Clinical or Healthcare-related disciplines
- Relevant technology or business equivalent qualifications
Who Can Apply?
This opportunity may be suitable for professionals working in:
- Clinical Data Management
- Clinical Research
- Centralized Monitoring
- Risk-Based Quality Management
- Data Surveillance
- Pharmacovigilance/Data Analytics
- Clinical Operations
- Healthcare Data Analytics
Candidates with experience in clinical trials and data-driven monitoring, along with basic SAS/SQL skills, may find this role particularly relevant.
How to Apply
Interested and eligible candidates can search for Parexel Job ID R0000042355 – Data Surveillance Analyst on the official Parexel careers portal and submit their application.
Job ID: R0000042355
Location: India – Remote
Company: Parexel
Role: Data Surveillance Analyst
Note: Candidates should verify the latest eligibility criteria, job status, and application details on the official careers portal before applying.
