Clinical Operations

Key Accountabilities

• 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).

Required Skills

• 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.

Knowledge and Experience

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

Education

• 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)