Clinical Affairs Specialist

JOB DESCRIPTION:

Primary Function

This role is responsible for managing study documentation and operational progress using Clinical Trial Management System, while maintaining the highest quality standards in clinical study execution. The position oversees documentation and study management support across clinical studies, including clinical investigations, post‑marketing surveillance, and clinical research, ensuring that all clinical study data comply with applicable regulations and SOPs.

Leveraging prior CRA experience, this role as a Clinical Site Operation (In‑house CRA) provides the opportunity to oversee clinical studies from a broader perspective and to support both operational and quality aspects of study execution. Additionally, the role collaborates with APAC and global partners to drive continuous process improvements across the organization.

We seek individuals who can maintain the highest level of quality in clinical studies while proactively addressing new challenges and contributing to innovation across the organization. This position is ideal for those who aspire to pursue various career paths in the future, including People Manager and Project Manager roles.

Major Responsibilities

• CTMS Management : Ensure compliance with clinical protocol and applicable regulatory requirements such as GCP, ISO14155 or GPSP through appropriate management, review, and maintenance of site-level TMF documentation in accordance with Work Instructions.
• Study Management Supports: Maintain study progress in the CTMS. In partnership with Abbott assigned field staff and in-house personnel, coordinate and support site activation and site close-out activities for clinical studies, ensuring completion, accuracy, and compliance of all required documentation, processes, and study materials.
• Study Document Development and Maintenance: Develop and update study specific documents in collaboration with internal/external personnel/parties.　
• Inventory Management for Clinical Trials:  Manage clinical trial inventory in accordance with applicable regulations and internal procedures, including vendor management (e.g., courier and logistics providers), development of study

-specific Inventory Management Plan, and coordination of shipment and return instructions for investigational devices.

Other Responsibilities:

• Continuous improvement to ensure high-quality clinical study deliverables on time and efficient document management and filing.
• Provides support and training to internal and external clinical personnel regarding the assigned clinical study protocol and/or internal processes.
• Reviews and analyzes data and documents for accuracy and completeness.
• Supports data query resolution.
• Supports the follow-up and resolution of findings from monitoring visits and audits in the study sites and/or region.
• Applies general clinical research processes and regulatory knowledge to actively improve processes and efficiencies.
• May act as a study expert for assigned clinical projects.
• May act as a subject matter expert for internal clinical processes.　
• Mentors less experienced clinical team members.
• Perform other related functions and responsibilities as directed by Manager.

Minimum Requirements

Education:

• Bachelor’s degree or equivalent

Background:

• Degree in science/health-related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences). 
• >2 Years of experiene in Field Clinical Research Associate, ensuring compliance with J-GCP, Ethical Guidelines for Medical Reserch Involving Human Subjectsm, and/or the Clinical Trial Act.

Skills:

• Fluent in English and Japanese (speaking, writing and reading).
• Proven expertise in Microsoft Office Suite.
• Excellent written and verbal communication skills, including negotiation and relationship management.
• Strong problem-solving, organizational, analytical and critical thinking skills.
• Full knowledge and understanding of GCP.
• Detail oriented and good problem-solving ability. 
• Ability to interact with senior internal and external personnel on significant matters, often requiring coordination between organizations.

Preferred Requirement

• Clinical monitoring experience under Medical Device GCP, ISO14155. 
• CRA experience under Medical Device GCP.
• Ability to work on teams and with multiple projects.
• Working knowledge of medical terminology required.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Medical & Scientific Affairs

DIVISION:

MD Medical Devices

LOCATION:

Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Not Applicable