Data Surveillance Analyst - based in selected EMEA locations

Parexel; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Home-based

Flexible working hours

Professional growth opportunities

Job summary

Parexel is seeking a Data Surveillance Analyst to support Data Surveillance planning, review, and reporting. You will develop DSPs, configure surveillance tech, and coordinate with project teams to ensure data quality and regulatory readiness.

You will collaborate with global teams, leverage RBQM methods, and use SAS/SQL/R, CTMS, and EDMS to deliver client-ready insights and actions.

Qualifications

• University degree in medical, biological science, pharmacy, or data analytics.
• Fluent English.
• Hands-on programming experience in SAS, R, and/or SQL is required.
• Experience with RBQM processes and data surveillance methods.
• Familiarity with centralized monitoring and Data Driven Monitoring.
• Proficient in CTMS, EDMS, and MS Office.
• Basic understanding of SDTM domains and data operations.
• Experience with CluePoints is a strong asset.
• Client-focused with strong quality orientation and teamwork.

Responsibilities

• Develop Data Surveillance Plans with KRIs, QTLs, and central statistical analysis.
• Configure and maintain Data Surveillance technologies (e.g., CluePoints).
• Create data import mappings and set up statistical parameters.
• Review data and support DS reviews per the project plan.
• Document findings in DS findings forms and tracking systems.
• Provide feedback to Technology teams to identify solutions.
• Identify data quality trends, outliers, and emergent issues.
• Attend investigator and internal/external audits and inspections.
• Communicate issues to FL and escalate where needed.
• Collaborate with DS team and project leads on actions.
• Compile signals into client-ready lists and document actions in CluePoints.
• Complete and file Central Monitoring Reports.

Skills

SAS/SQL/R

RBQM knowledge

Data surveillance

Centralized monitoring

CTMS

EDMS

MS Office

SDTM basics

CluePoints

Data analysis

Presentation skills

Education

University degree

Tools

CluePoints

CTMS

EDMS

MS Office

Job description

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 elevate 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!