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Senior Clinical Operations Professional

3 weeks ago

Bengaluru, Karnataka, India beBeeClinicalTrialCoordinator Full time ₹ 1,04,000 - ₹ 1,30,878
Job Overview

This is a dynamic and rewarding role that will see you playing a pivotal part in the success of clinical trials in Japan. As a skilled and experienced Clinical Trial Coordinator, you will be responsible for ensuring the smooth operation of these trials, from document management to coordination with sites and vendors.

Key Responsibilities
  • Document Management: Ensure that all documents are accurately coded and named according to the Central File Maintenance Plan (CFMP), and that they are properly archived and managed in the Central Files office.
  • Tracking and Retrieval: Conduct photocopying, printing, distribution, and retrieval of documents as required, while performing basic quality checks to ensure accuracy and integrity.
  • System and Process Compliance: Maintain the Clinical Trial Management System (CTMS) and study-specific site trackers, and 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, and coordinate payments and invoices with finance specialists.
Required Skills and Qualifications
  • 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, and 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, ensuring 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 to demonstrate a sense of urgency and proactive approach in supporting team deliverables.
  • Communication: Excellent verbal and written communication skills, and strong interpersonal skills for effective team collaboration.
Education and Certification
  • Degree in biological sciences, pharmacy, or a health-related discipline (preferred), or equivalent nursing qualification or relevant clinical research experience.
  • N2 or N3 certification in Japanese fluency (reading, writing, and speaking).