Clinical Data Analyst I

Parexel; Petaling Jaya; On-site; MYR 67,000 - 100,000; Full time

Job summary

Parexel is seeking a Data Management professional in Malaysia to lead data cleaning, review activities, and support data processing from database setup to lock. You will contribute to DM documents and ensure SOP/ICH-GCP compliance while participating in UAT for clinical database setups.

You will track CRFs, support data entry, and help maintain training compliance across job roles, with emphasis on accuracy, timelines, and collaboration within the study team. English proficiency required.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• Familiarity with ICH-GCP guidelines and applicable SOPs.
• Experience in clinical data management or related fields.
• Basic knowledge of data management processes and validation flow.

Responsibilities

• Lead data cleaning and data review activities (Co-Primary/CDA).
• Support data processing from database setup to lock.
• Setup and maintain DM documents per SOPs/ICH-GCP.
• Lead/perform UAT for clinical database setups.
• Track and review CRFs; assist data entry when needed.
• Ensure compliance with procedures and training requirements.

Skills

Data cleaning

Problem solving

Time management

Team collaboration

Oral and written communication

Learning ability

Attention to detail

English fluency

Education

Bachelor's degree

Tools

InForm

Rave

Veeva

Datalabs

ClinBase

Job description

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:

• Bachelor’s degree and/or other medical qualifications or relevant industry experience.