Clinical Data Analyst I
ParexelPetaling Jaya, Selangor, Malaysia5 jam yang lalu
Penerangan pekerjaanEvidence 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 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 the job description Written and oral fluency in English 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 the clinical research industry Basic knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHO DRUG) 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 Bachelor’s degree and / or other medical qualifications or relevant industry experience
Clinical Data Analyst I
Join to apply for the Clinical Data Analyst I role at Parexel
Responsibilities
- Responsible for or lead data cleaning and data review activities (Co-Primary CDA / Primary CDA), including query management and manual / SAS listing reviews.
- Lead data processing activities from database setup to database lock, such as external vendor data reconciliation.
- Setup and support data management documents, ensuring proper documentation per Standard Operating Procedures, ICH / GCP Guidelines.
- Lead or perform user acceptance testing on clinical database setups.
- Review protocols and EDC entry screens when required.
- Track and review CRFs; provide data entry support where needed.
- Ensure compliance with SOPs and ICH / GCP Guidelines.
- Lead functional QC activities on databases and / or patient data as per business needs.
- Maintain training compliance for assigned job roles, including on-the-job training.
- Address training needs per development goals identified.
Skills
Knowledge and Experience
Education
Seniority Level
Entry level
Employment Type
Full-time
Job Function
Research, Science, and Analyst
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care
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