Clinical Data Analyst I

3 weeks ago

Subang Jaya, Selangor, Malaysia Parexel Full time

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: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.Training: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 reasoningCommitment 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 timelinesEvidence of ability to work collaboratively within a team environmentGood interpersonal, oral and written communication skillsLearning ability and knowledge sharing approach; swift understanding of technologies and new processesA flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environmentsEvidence of accountability relative to Key Accountabilities in Job DescriptionWritten 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 proceduresBasic knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, Datalabs, ClinBase.)Basic understanding of Clinical Study Team roles within Data ManagementExperience in clinical research industryBasic 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-outBasic knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data ValidationEducation:Bachelor's degree and/or other medical qualifications or relevant industry experience.

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