Tokyo,Osaka,10.0M ～ 12.0M

Job Description
Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.

Clinical Operations is the organisational home for the operational delivery and programme and project management of clinical projects, drug and non-drug.

Skill-set
- Excellent Communication and relationship building skills
- Proven ability to prioritize and manage multiple tasks with conflicting deadlines
- Excellent interpersonal skills and proven ability to facilitate team building and team work
- Proactively identifies risks and issues and possible solutions
- Demonstrates ability to prepare and deliver study related training materials
- Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
- Demonstrates professionalism and mutual respect
- Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
- Proven learning agility
- Basic knowledge and experience of quality management

Nice to have
- Project management certification
- Ability to interact widely and effectively within the company at all levels. Good networking skills
- In-depth knowledge of clinical and drug development process
- Fiscal and financial awareness

Tokyo,11.0M ～ 14.0M

Manage the Business:
- Supports the Country Business Manager, Regional Business Managers & Clinical Support Specialist in the sales processes to ensure revenues for that region are achieved.

- Creates, monitors and applies price management principles in the region in-conjunction with commercial business analyst.

- Clearly demonstrates an in-depth knowledge of the dealer contract and tendering environment to benefit and impact
commercial business.

- Participates in meetings with dealers to drive relations, dealer perception and awareness of the price management principles.

- Uses and educates the team on the commercial toolbox so that sound commercial judgements and actions are taken.

- Leads and delivers the commercial business plan objectives by using a high level of business acumen.

- Create strong relationships with key stakeholders to allow for the development of value-based opportunities.


Customer:
- Supports dealer interaction enhancing experience and sales opportunities.

- Maintains a general knowledge of applicable products/procedures and competitor products.

- Ensures business planning and pricing is efficient, effective, profitable, and compliant with company guidance while
meeting the needs of our customers.

- Leads comprehensive dealer business reviews as needed, including defense of current business, identification of new opportunities, and communication of custom solutions.

- Has high level knowledge about the ordering process and key contacts within dealer accounts to improve this process as applicable.

- Demonstrates a strong ability and use of communication skills with internal and external stakeholders.

- Analyze, understand, and communicate causes of lost business and collaborate with business/sales teams on plans to recover.

- Understands dealer structure, roles, and responsibilities to aid the collaborative approach.

- Leads and participates in commercial tasks to protect current business and creates new opportunities via this business route.

- Leads and manages the assessment of dealer commitment to contracts and products to uncover opportunities to grow commitment or reassign pricing tier.


Collaboration:
- Leads collaboration to utilize company resources across divisions as needed effectively and efficiently to identify, qualify, and prioritize opportunities to maximize growth and profitability.

- Strategize with relevant clinical sales teams and lead a comprehensive approach to new opportunities, stakeholder
alignment, and value analysis engagement in assigned accounts.

- Maintains relationship with all colleagues to support business requirements.

- Demonstrates strong communication abilities with internal and external stakeholders

- Understands our company structure and the associated roles to support the collaborative approach.

- Manages and collaborates in commercial tasks to protect current business and creating new opportunities.

- Analyze, understand, and communicate causes of lost business and collaborate with business/sales teams on plans to recover.


Organizational:
- Meets or exceeds the administration requirements related to job role.

- Adheres to company policies, process, and procedures consistent with company timelines.

- Understand their role and how it fits into the company's structure to ensure dealer and business objectives are met.

- Proves in their actions that they understand the importance of teamwork and how it aligns with the companies’ policies and expectations.

- Working closely with the Country Business Manager, Regional Business Managers, Commercial Business Analysts,
Commercial Account Specialists and the Clinical Support Specialists to ensure commercial goals are achieved and aligned with business plan.

Tokyo,Osaka,5.0M ～ 8.0M

Primary Function:
The position will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently. May act as assessor of peers for assessment visit purposes (as approved).

Key Responsibilities:
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.

- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.

- Conduct activities following Clinical Monitoring Plan

- Perform investigational product (IP) inventory, reconciliation and reviews storage and security.

- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.

- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.

- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.

- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

- May provide training or mentorship to more junior level CRAs.

- May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Trial Manager (CTM), or operational line manager.