Data Surveillance Analyst - based in South Africa, Romania, Serbia

Parexel; United States; Teletrabalho; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Parexel seeks a Data Surveillance Analyst (DSA) to analyze scientific data and support surveillance processes. You will develop DSPs, review Quality Tolerance Limits, and present findings in DS meetings.

The role involves configuring surveillance technologies, creating data mappings, and documenting actions in tracking systems. Ideal candidates have a medical/biological science background, fluent English, and basic SAS/R programming.

Qualificações

• Bachelor’s or higher in a relevant field (medical, biological science, pharmacy or data analytics).
• Fluent English and strong written/verbal communication.
• Basic SAS or R programming experience.
• Experience with RBQM and centralized monitoring concepts.
• Familiarity with Data Driven Monitoring practices.
• Proficiency in data analysis, trend identification and issue triage.
• Experience with CTMS, EDMS and MS Office.
• Understanding of SDTM domains and data operations basics.
• Experience with CluePoints is a plus.
• Client-focused with strong quality orientation.
• Able to work in global virtual teams and manage time effectively.
• Excellent interpersonal and presentation skills.

Responsabilidades

• Analyze scientific and operational data to support Data Surveillance processes.
• Review project-specific Quality Tolerance Limits and DSPs.
• Attend internal/external Data Surveillance meetings and present findings.
• Configure and maintain data surveillance technologies (CluePoints Central Monitoring Platform).
• Create data import mappings and KRIs; set up statistical parameters.
• Document findings in DS Findings Form and_issue tracking systems.
• Collaborate with DS team to correlate signals from various sources.
• Support DS Review meetings and drive action decisions with project leads.
• Prepare and file the Central Monitoring Report and related documentation.
• Escalate data quality issues to appropriate stakeholders promptly.

Conhecimentos

Fluent English

Independent work

Time management

Communication skills

Analytical mindset

Formação académica

University degree in medical/science/pharmacy/data analytics

Ferramentas

SAS

R

CTMS

EDMS

MS Office

Descrição da oferta de emprego

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 position is open only to candidates currently based in and legally authorized to work in one of the following EMEA locations: South Africa, Serbia or Romania. Fully home-based working is available in all three 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 escape 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.

• Basic SAS or R programing experience required.

• 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.