Data Surveillance Analyst - based in selected EMEA locations
Parexel · Romania
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
This home-based position is available to candidates in selected EMEA locations. Applicants must be based in one of the eligible locations.
Picture Yourself At Parexel:
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. 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.
What You'll Do At Parexel:
Data Surveillance Plan Development and Technology Configuration:
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., CluePoints 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.
Data Surveillance Review:
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.
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 Project Leads 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 CluePoints Issue Management system (links to IH for any on-site interventions required).
Complete, share, and file Central Monitoring Report.
Here are a few requirements specific to this advertised role:
University degree (medical, biological science, pharmacy, and/or data analytics).
Fluent English.
Hands-on programming experience in SAS, R, and/or SQL is a must-have.
Experience with Risk-Based Quality Management (RBQM) processes and data surveillance methods.
Familiarity with centralized monitoring and Data Driven Monitoring practices.
Proficient in data analysis, trend identification, and issue triage.
Proficient in relevant software: CTMS, EDMS, MS Office.
Basic understanding of SDTM domains and data operations concepts.
Experience with CluePoints would be a strong asset.
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.
Why join us:
Be part of groundbreaking projects that are pushing the boundaries of the industry. Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. Enjoy work life balance and flexible working hours!
If this job does not sound like the next step in your career, but you know of someone who would be a perfect fit, send them the link to apply!