※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
This position is a professional individual contributor that is responsible for taking leadership in all clinical data management activities for assigned trial(s) and Japan NDA submission as representative from Data management function. This position is also responsible for taking leadership in TA level and supervise CDML/ CDM as required. Drive data management deliverables in a timely and efficient manner in close collaboration with cross- functional counterpart.
Responsible for Data Management strategy, planning, execution of activities of assigned TA.
Ensure the quality of clinical trial database, and deliver timely, accurate & secure database for clinical development of the analysis.
- M.S. or equivalent is required.
- 6-8 years of pharmaceutical industry experience overall including clinical development experience.
- Minimum 5 years of experience in data management.
- In-depth Knowledge of international guidelines regarding clinical trials (e.g. ICH guideline, 21 CFR part11, ER/ES, eDATA submission requirement)
- Proven knowledge of good data management practice
- In-depth knowledge of protocol and current clinical drug development processes
- Working knowledge of data management system (EDC, LSAF, etc.)
- Working knowledge of dictionary coding and understanding medical dictionaries (e.g. MedDRA, WHO-DD)
- Working knowledge of SDTM and understanding SDTM IG
- Enough vendor management oversight experience
- Ability to lead cross-functional team interpreting data requirements.
- In-depth project driving skills and knowledge of team management principles are required.
- Strong oral and written communication skills in both English and Japanese.
- Demonstrates influence, negotiation and conflict resolution skills.
- Good problem-solving skills.
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.