
Clinical Data Officer, Data Management, Sics
5 days ago
Manage the Clinical Data Officers in Clinical Data Management deliverables including Case Report Form (CRF)/e-CRF design, database design and set-up, validation definition and programming, Data Management Plan and study database deliverables.
Lead the implementation of CDISC SDTM framework and OMOP Common Data Model for data collection across research studies, streamlining the data standardisation during data collection and data integration phases.
Develop Clinical Data Management documentations/guidelines and drive process standardisation across research studies in accordance to Good Clinical Practices (GCP) and Good Clinical Data Management Practices.
Develop and implement proactive quality control audits/quality management plans across research studies to ensure accuracy, completeness and proper usage of systems from Clinical Data Management perspective.
Work closely with clinical trial industry sponsors on Clinical Data Management protocols, medical coding and regulatory data submissions.
Lead/support continuous Clinical Data Management process and technology improvements as assigned by Head of Data Management.
Job Requirements
A Bachelor/Master Degree in Public Health, Clinical Research, Life Sciences, Computer Science or related field.
5 years of relevant experience working in academic research, pharmaceutical/biopharmaceutical companies or clinical contract research organization (CRO).
Experiences with industry standard Electronic Data Capture (EDC) tools such as Medidata Rave, Oracle Clinical One, Veeva.
Basic programming skills in any language (Python preferred).
Familiar with Business Intelligence (BI) reporting tools such as Power BI.
Professional experience using Microsoft Office tools (advanced proficiency in Excel).
Organizational, numerical and analytical skills with keen attention to detail.
Project management skills with demonstrated ability to work in an environment with multiple projects and timelines.
Knowledge/experience on Good Clinical Practices (GCP), Good Clinical Data Management Practices, 21 CFR Part 11, CDISC SDTM standards and regulatory data submissions.
Good team player and communication skills.
Effective team management skills.
**Type of Employment**: Full-Time
**Minimum Experience**: 5 Years
**Work Location**: NUS
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