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,Osaka,10.0M ～ 14.3M

Leads the creation of the strategic global medical plan for Pharma Therapeutic Area product, in alignment with the countries’ medical planning and in alignment with the global business function and other internal stakeholders

Executes some strategically important parts of the global medical plans, like KOL relationship management activities

Oversees and monitors the execution of the global medical plans

Contributes to / provide the medical strategy for global Phase IV medical affairs studies to support the commercial success of our Pharma Therapeutic Area products

Plans and coordinates the design, conduct, analysis, reporting and publication of Phase IV Studies

Contributes to / Provides the strategic review of our Pharma Therapeutic Area ISS and NIS studies

Provides medical affairs input to global clinical development programs

Ensures all regional studies are consistent with agreed medical strategy

Oversees and monitors the long-term communication plans; this includes the long term medical affairs study and data generation plans

Interprets information from clinical development studies, medical affairs studies, and from external sources, to generate communication materials and documents for internal and external use, including slide decks, training material, Q&As and others

Leads the Global Content Network for medical information document generation. Updates, organizes and maintains the global medical information documents within the proprietary repository

Provide Medical review of promotional material from the GBT for global use e.g. product monographs, brochures, press releases, Q&As, field communications

Contributes to the Global Brand Team’s work by providing medical expertise and insight on commercial issues

Provides Medical Affairs input to core labeling and pharmacovigilance documents for marketed products

Ensures excellence in medical governance activities, including the collaboration with co-development partner companies

Establishes professional relationships with global clinical investigators, opinion leaders, and consultants in the medical community

Represents our company's viewpoint on products to key opinion leaders, scientific advisors, health authorities and to other external stakeholders

Plans and monitors the global medical affairs budget, in collaboration with the global business function and our external co-development partners

Maintains and develops relationships with scientific communications agencies, clinical research organizations, and other service providers as required to support excellence in global launch and post-launch medical affairs operations

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