Data Coordinator
- Taipei City
- Permanent
- Full-time
- Performs data review of clinical trial data, including query management
- Performs reconciliation review of external data against EDC data
- May assist in creating study documents or assist in running study reports and metrics
- Performs additional review activities for interim and final database locks as needed.
- Files study documentation in electronic Trial Master File (eTMF) and department project files.
- Performs periodic quality review of eTMF documents.
- Assists with taking meeting minutes and documenting/tracking study data management activities.
- Performs data archival activities.
- Performs inspection readiness activities and supports CDM team during internal and regulatory inspections
- May support the set-up and testing of study data collection tools.
- Assists with quality review of above activities performed by the CRO, as needed.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Performs other duties as assigned.
- Associate or Bachelor's Degree preferred
- Ideally 1 or more years relevant work experience, or equivalent combination of training and experience.
- Familiar with electronic data collection systems
- Preferred knowledge of data management best practices & technologies as applied to clinical trials.
- Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Strong attention to detail, and organizational skills
- Good time management skills
- Quick learner and comfortable learning new technologies and systems
- Good knowledge of office software (Microsoft Office).
- Is comfortable with ambiguity.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others