Clinical Data Analyst I

Petaling Jaya - Malaysia

Monthly Salary: Not Disclosed

Posted on: 06-11-2025

Vacancies: 1 Vacancy

Job Summary

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

Key Accountabilities:

Data Validation (cleaning)

Responsible for/start to lead data cleaning and data review activities (Co-Primary CDA/Primary CDA) e.g. query management and manual/SAS listing reviews.
Support/start to lead data processing activities from database setup to database lock e.g. external vendor data reconciliation.

Data Management Documents/Plans (Trial Master File)

Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures ICH/GCP Guidelines.

Study Start-Up Activities and User Acceptance Testing (UAT)

Start to lead/perform user acceptance testing on clinical database setups.
Start to review protocols and EDC Entry Screens if required.

Data Tracking and Entry

Track and review CRFs. Support data entry where required.

Project Quality Management & Compliance Training

Ensure compliance to Standard Operating Procedures ICH/GCP Guidelines.
Support/start to lead functional QC activities on databases and/or patient data as per business needs.
Maintain training compliance as per Job Roles assigned including On-the-Job training.
Address training needs as per Development Goal/s identified.

Skills:

Evidence of strong problem-solving skills and logical reasoning
Commitment to first time quality including a methodical analytical and accurate approach to work activities (attention to detail)
Time management and prioritization skills in order to meet objectives and timelines
Evidence of ability to work collaboratively within a team environment
Good interpersonal oral and written communication skills
Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments
Evidence of accountability relative to Key Accountabilities in Job Description
Written and oral fluency in English

Knowledge and Experience:

Demonstrates technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
Basic understanding of data management processes and data validation flow (e.g. Data cleaning DB lock)
Basic understanding of relevant ICH-GCP Guidelines local regulatory requirements and PAREXEL SOPs and study specific procedures
Basic knowledge of Clinical Data Management Systems (e.g. InForm Rave Veeva Datalabs ClinBase.)
Basic understanding of Clinical Study Team roles within Data Management
Experience in clinical research industry
Basic knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
Basic knowledge of Data Management Operational processes and tasks during study start-up conduct and close-out
Basic knowledge of Database set-up activities including but not limited to Database Configuration Specifications and setup of Data Validation

Education:

Bachelors degree and/or other medical qualifications or relevant industry experience.

Required Experience:

When our values align theres no limit to what we can achieve.At Parexel we all share the same goal - to improve the worlds 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...

Key Accountabilities:

Data Validation (cleaning)

Responsible for/start to lead data cleaning and data review activities (Co-Primary CDA/Primary CDA) e.g. query management and manual/SAS listing reviews.
Support/start to lead data processing activities from database setup to database lock e.g. external vendor data reconciliation.

Data Management Documents/Plans (Trial Master File)

Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures ICH/GCP Guidelines.

Study Start-Up Activities and User Acceptance Testing (UAT)

Start to lead/perform user acceptance testing on clinical database setups.
Start to review protocols and EDC Entry Screens if required.

Data Tracking and Entry

Track and review CRFs. Support data entry where required.

Project Quality Management & Compliance Training

Ensure compliance to Standard Operating Procedures ICH/GCP Guidelines.
Support/start to lead functional QC activities on databases and/or patient data as per business needs.
Maintain training compliance as per Job Roles assigned including On-the-Job training.
Address training needs as per Development Goal/s identified.

Skills:

Evidence of strong problem-solving skills and logical reasoning
Commitment to first time quality including a methodical analytical and accurate approach to work activities (attention to detail)
Time management and prioritization skills in order to meet objectives and timelines
Evidence of ability to work collaboratively within a team environment
Good interpersonal oral and written communication skills
Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments
Evidence of accountability relative to Key Accountabilities in Job Description
Written and oral fluency in English

Knowledge and Experience:

Demonstrates technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
Basic understanding of data management processes and data validation flow (e.g. Data cleaning DB lock)
Basic understanding of relevant ICH-GCP Guidelines local regulatory requirements and PAREXEL SOPs and study specific procedures
Basic knowledge of Clinical Data Management Systems (e.g. InForm Rave Veeva Datalabs ClinBase.)
Basic understanding of Clinical Study Team roles within Data Management
Experience in clinical research industry
Basic knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
Basic knowledge of Data Management Operational processes and tasks during study start-up conduct and close-out
Basic knowledge of Database set-up activities including but not limited to Database Configuration Specifications and setup of Data Validation

Education:

Bachelors degree and/or other medical qualifications or relevant industry experience.

Required Experience:

Key Skills

Data Analytics
Microsoft Access
SQL
Power BI
R
Data Visualization
Tableau
Data Management
Data Mining
SAS
Data Analysis Skills
Analytics

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About Company

Parexel

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more

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