※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
- Manage project team activities; leveraging internal resources, and expertise knowledge
- Manage aspects of CRO outsourcing, including : request for proposal development, CRO selection process, and the day to day study management activities of CROs.
- The management through of CRO(s) ; Study sites including regulatory documents, CRO monitorvisit reports and site correspondence. Drug supply and use, enrollment of subjects, study timelines, financial information, Serious Adverse Events, performance metrics, data flow, etc.
- Review of site ICFs
- Involvement in discussion and help develop contingency/risk management plans for projects and assist Manager, Clinical Operations, Director of Clinical Operations in the preparation and execution of sound development strategies.
- Create, track, and manage project budgets and timelines with an ability to provide comparison updates offinancial accruals versus projected budgets.
- Interface with Regulatory Affairs, Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs.
- Review and approve vendor invoices for payment.
- Ability to travel (no more than annual average of 25%).
- Bachelor's Degree is required. An advanced degree in scientific discipline, business/finance courses is preferred.
- 3+ years of clinical project management experience gained within a CRO or Pharmaceutical Company working on Phase I - IV multinational clinical studies. Later stage clinical study experience a plus.
- Regulatory and compliance knowledge, including Good Clinical Practices (GCPs)
- Strong organizational skills and ability to deal with competing priorities, also strong reasoning and problem solving ability.
- Excellent communication skills (written and verbal), along with presentation skills.
- Knowledge of global clinical trial management. Ability to work with a team to assemble a plan yet execute on the details.
- Protocol, ICF, CRF, CSR design and review.
※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.