Remote Data Surveillance Analyst Job at Parexel | Apply Now
A rare chance to work in the Parexel Data Surveillance Analyst role has emerged, offering a unique opportunity to contribute to the analysis of scientific and operational data. This role is essential for supporting the Data Surveillance process and ensuring quality in project-specific operations. Interested candidates are encouraged to apply before the deadline.
About The Company
Parexel is a leading global biopharmaceutical services organization that provides a broad range of services to clients in the life sciences sector. The company specializes in accelerating the development of innovative products and improving the quality of the clinical research process. With a commitment to excellence, Parexel operates in various locations worldwide, providing tailored solutions to meet the needs of their clients.
- Position: Data Surveillance Analyst
- Job ID: R0000045688
- Location: India (Remote)
Parexel Data Surveillance Analyst Job Description
The Parexel 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.
Parexel Data Surveillance Analyst: 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 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.
- 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 oriented work environment, building partnerships and collaborative relationships.
- 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.
- Complete, share, and file Central Monitoring Report.
- All other duties as assigned by management.
Eligibility Criteria
- 2 or more years of relevant medical, clinical or data management work experience recommended.
- Experience of working within an adaptive monitoring design study, and/or participating in a Central Monitoring/Data Surveillance process highly recommended.
- Basic SAS programming and/or SQL script writing required.
Required Skills
- 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.
Education
- Educated to a degree level (medical, biological science, pharmacy and/or data analytics, preferred) or relevant clinical, technology or business equivalent.
Qualified candidates are encouraged to apply for the Parexel Data Surveillance Analyst position. This role presents an excellent opportunity to contribute to impactful projects in the life sciences sector. Interested individuals should submit their applications before the deadline to ensure consideration for this position.
