Clinical Data Analyst I - Kuala Lumpur Malaysia

**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:** * 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 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:** * 1-2+ years of experience in Clinical Data Management, Clinical Research, Study Start-up, Clinical Operations, Pharmacovigilance, Medical Coding, CRC, CTA, CRA support, or related clinical research functions * 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.