- Utilize Data Management Expertise to Expedite Clinical Trials
- Contribute to Approval of Innovative Medicines
- World leading global Medical Device company
- Design and implement clinical protocols and data collection systems.
- Develop systems for organizing data to analyze, identify and report data and trends.
- Manage data management issues by reviewing protocols for cross-project consistency, and identifying standard Case
- Report Form (CRF) modules to meet objectives.
- Develop data quality plans.
- Provide early strategic input into protocol design focused on data management issues.
- Review and resolve data discrepancies for standardized data validation systems and procedures.
- Prepares reports of clinical trial studies for internal validation and cross validation studies.
- Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- May act as a mentor to colleagues or may direct the work of other lower level professionals
- Works independently under limited supervision to determine and develop approach to solutions.
- Coaches and reviews the work of lower level specialists; may manage projects / processes.
- Organizational Impact: May be responsible for entire projects or processes within job area.
- Bachelors degree (Science, Engineering, Pharmaceutical Sciences)
- Extensive data management operations experience for clinical trials
- Experience in using EDC
- Smooth communication, business level English, native level Japanese
- General knowledge about IT
- aWork in an international environment, clear career development opportunities, contribute to global clinical studies