Data Surveillance Analyst - based in South Africa, Poland, Romania, Lithuania

This position is available in the following EMEA locations: South Africa, Lithuania, Poland, and Romania, with fully home-based working available in all of these 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, preferred).

• Fluent English.

• 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.

• Basic SAS programing or SQL or other programming languages with data analytics experience required.

• Proficient in relevant software: CTMS, EDMS, MS Office.

• Basic understanding of SDTM domains and data operations concepts.

• 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.

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program.  We offer competitive financial packages, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.