Clinical Quality Specialist
Clinical Quality Specialist
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Job Description
JOB DESCRIPTION:
Primary Function
This role is designed to drive efficiency and productivity in clinical trial execution while maintaining the highest quality standard. The position ensures that clinical study data utilized for regulatory submissions comply with relevant regulations. Additionally it drives quality management and continuous process improvement to ensure adherence to regulatory requirements throughout clinical study execution. This role may offer a pathway to managerial positions and/or broader responsibilities within the APAC region or globally allowing candidates to expand their expertise across diverse regions.
We seek individuals who are eager to embrace challenges and drive innovation in clinical trial execution while upholding the highest quality standards. This role is ideal for those who aspire to develop their careers and take on various positions in the future including People Manager and Project Manager roles.
Major Responsibilities
GCP Compliance: Verify GCP compliance of foreign data submission for product approval.
Regulatory Audits: Support GCP/GPSP conformity audits by competent regulatory authorities.
Coaching and Knowledge Sharing: Demonstrate thorough knowledge of clinical research conduct laws regulations and standards and coach others in compliance with applicable company SOPs and policies.
Clinical Quality:
Primary responsibility is ensuring implementation of quality plan at every stage of the Clinical Trial process/operations.
Implement quality assurance regulations.
Write and revise standard operating procedures.
Support and facilitate audits and regulatory inspections.
Supervise all quality control aspects of the process (laboratories studies clinical research testing operations).
Ensure that standards are met and report potential issues either with quality or reliability of testing procedures.
Lead implementation of new regulations.
May support quality training.
Process Management:
Ensure high-quality clinical study deliverables on time.
Ensure efficient document management and filing.
Manage and oversee clinical vendors to leverage external resources and ensure quality deliverables from them.
Manage multi-regional processes.
Minimum Requirements
Education:
Bachelors degree or equivalent
Background:
>5 Years of experiene in clinical study roles 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.
Strict attention to detail.
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
Preferred Requirement
Degree in science/health-related field (e.g. Biology Nursing Biomedical or Veterinary Sciences).
Experience in quality management and/or quality assurance.
Clinical monitoring experience under Medical Device GCP ISO14155.
Project management experience under Medical Device GCP.
The base pay for this position is
N/AIn 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 5-6-10TsukijiChuo-ku
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Unclear Seniority
Employment Type
Full-Time
