Role overview

Qualifications

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
Basic SAS programming or SQL or other programming languages required

Responsibilities

Support the development of a robust Data Surveillance Plan, including Key Risk Indicators and Quality Tolerance Limits
Review relevant data via the scoped technologies and additional sources as required
Document findings from Data Surveillance activities in the DS Findings Form and Issue Tracking systems
Participate in Investigator and other external or internal meetings and audits

Key facts

Remote from: Poland, Romania, Africa
Full time
Data Analyst
English

Hard skills

Computer And Network Surveillance Base SAS SQL (Programming Language) Statistical Analysis Idms

Other skills

Microsoft Office
Communication
Social Skills
Time Management
Problem Solving
Teamwork

About the company

Parexel

Contract Research Organizations (CRO)

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company details

Company typeXLarge

IndustryContract Research Organizations (CRO)

Company size10001

Links

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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 position is open only to candidates currently based in and legally authorized to work in one of the following EMEA locations: South Africa, Lithuania, Poland, or Romania. Fully home-based working is available in all four 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.
Basic SAS programing or SQL or other programming languages required.
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.
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.