【900～1400万円】【R D】Japan Clinical Operation Program Development L…

【求人No NJB2218319】
■ 職務内容 / Job Description
Lead Japan Clinical Operation Program （JPD Lead） is accountable/responsible for leading the project planning for clinical operation in Japan R D. The span of activities is broad covering clinical activities in both early and late drug development registration/submission and post registration product maintenance phases and will include local and global working.
The JPD Lead is responsible for planning oversight on related studies and mediator among Japan study team project team and Global project/clinical team.
The JPD Lead is one of the key members of Japan project team to represent Clinical Operation arena and to contribute JPT deliverables.

■Key Responsibilities
1. Project Level
・Contribute to planning and execution of Japan clinical operational part in Japan development plan with high quality insights from clinical operation arenas until ID approval and responsible for leading a cross functional team of clinical experts in the planning and delivery of a defined clinical studies to quality budget time managing resource and risk
・Lead strategies for the site selection/patient recruitment in feasibility assessment through external key stakeholders involvement to optimize the project deliverables
・Responsible for project management including the development baselining and maintenance of realistic up to date and appropriate quality project and study plans in agreed study planning systems
・PMDA interaction; Contribute to operational strategic interaction with PMDA
・JNDA; Responsible for health authority GCP inspection management
・Key Investigators Management/Engagement ; Act as a key point of contact for clinical operations related relationship with Key investigators and National Lead Investigators
・PUBLICATION; Contribute to author selection by providing required information and act a key point of contact for author/KEE

2. Study Level
・Lead program operational feasibility assessment including project management of the scope schedule and budget
・Provide operational input into study feasibility study specifications and vendor/partner contracts
・Handover study specification including the strategic context and the PMDA’s feedback of the clinical study discussed at Japan project team to study team
・Lead a large/complex work situation or oversight a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal stakeholders or external partners engagements
・Act as a point of contact with external partners for externally managed/outsourced studies as needed
・Oversight of the study delivery through regular communications with Global counterpart and relevant persons in Japan study/site management functions to anticipate study requirements and mitigate risks

3. Collaboration with Marketing Company
For study support act as a point of contact to MSL in Medical Affairs to collaborate on e.g. Programme feasibility/KEE Engagement developing site candidates list information exchange on sites
4. Others
Task outside projects; May be assigned responsibility for leadership and program/project management of non drug project work as the representative of Japan for the global initiatives developing new processes in Japan R D or the industry activities