Clinical Operations

3 weeks ago

Bengaluru, Karnataka, India Thepharmadaily Full time
Job Description

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)

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