Document Management:
Track, scan, code, and apply naming conventions to documents per the Central File Maintenance Plan (CFMP).
Archive and manage paper documents in the Central Files office.
Conduct photocopying, printing, distribution, and retrieval of documents as required.
Perform basic quality checks to ensure document accuracy and integrity.
System and Process Compliance:
Maintain the Clinical Trial Management System (CTMS) and study-specific site trackers.
Monitor compliance with systems/processes, including annual reporting obligations and Site Compliance related to the Safety Information System (SIS).
Operational Support:
Organize translations of study documents, liaising with translation vendors and managing approval workflows.
Coordinate payments and invoices, collaborating with finance specialists for internal follow-ups.
Handle courier shipments of study documents to sites, vendors, and clients.
Collect internal signatures for site documents (e.g., confidentiality agreements, clinical site agreements).

Language Proficiency:
Japanese fluency (N2 or N3) – reading, writing, and speaking.
Technical and Industry Skills:
Experience supporting document collection, customization, and review for clinical trials in Japan.
Knowledge of clinical trial documentation, processes, and systems.
Familiarity with CROs or the Life Sciences industry (preferred).
Project and Team Collaboration:
Work closely with sites, investigators, and project management teams to support study delivery.
Ensure quality and compliance in all research activities.
Time and Task Management:
Prioritize multiple tasks, meet tight deadlines, and use strong analytical and problem-solving skills.
Demonstrate a sense of urgency and proactive approach in supporting team deliverables.
Communication:
Excellent verbal and written communication skills.
Strong interpersonal skills for effective team collaboration.

Prior site management or clinical research experience with a solid understanding of:
Clinical trial methodologies
Terminology related to clinical studies

Degree in biological sciences, pharmacy, or a health-related discipline (preferred)
or equivalent nursing qualification or relevant clinical research experience
Japanese Language Proficiency:
N2 or N3 certification in Japanese fluency (reading, writing, and speaking)

Clinical Operations