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.

Tokyo,10.0M ～ 13.0M

Essential Job Functions/Duties:
・ Develop and execute an annual medical education plan for the assigned specialties and geography, in partnership with Medical Education, Division & Marketing leadership/stakeholders based on current and future product portfolio and procedural trends.

・ Collaborate with relevant Divisional & Marketing stakeholders and resources to develop content to support educational programs with appropriate messaging that meets customer and company needs, as well as compliance and regulatory standards.

・ Develop, implement, and maintain policies, procedures, criteria, and qualifications for attendees, programs, and divisional representatives.

・ Responsible for annual budget projections and tracking of activities for medical education training programs.

・ Review, approve, and manage the calendar of educational events to ensure structure and alignment with Medical Education and divisional goals.

・ Identify HCP consultant partners that support education initiatives in collaboration with division stakeholders. Work closely and maintain regular communication with identified HCP consultants on all initiatives while maintaining compliance and legal standards.

・ Coordinate and support the implementation of medical education training programs, providing an overview of training course goals and learning objectives, course criteria, and processes as part of a needs assessment for customer programs.

・ Continuously evaluate and improve the strategy for Medical Education by monitoring metrics and listening to feedback from customers and employees. Take action and resolve issues and gaps quickly and effectively.

・ Report transparently and timely to Medical Education leadership.

・ Meet deadlines and complete administrative tasks such as expenses, training, reporting, policy acknowledgements, etc., in a timely manner.

・ Willingness and availability to travel on company business.

・ Must work and interact effectively and professionally with and for others throughout various levels of the global organization.

・ Within the scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met.

・ Demonstrate a clear understanding of and adherence to compliance and legal standards and regulatory processes relative to technical and procedural education delivery and materials.

・ Understand and be accountable for conducting business with integrity and in compliance with applicable standards, including the company's policies.

・ Maintain our culture, values, and commitment to Ethics and Compliance by recognizing, demonstrating, and enforcing appropriate and compliant behavior.

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