Clinical Data Analyst I

6 days ago

Petaling Jaya, Selangor, Malaysia Parexel Full time

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.

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.

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