Clinical Trials Manager

4 days ago

Hong Kong, Central and Western District, Hong Kong SAR China Bristol Myers Squibb Full time

Transforming Patients' Lives through Science at Bristol Myers Squibb

Overview

As a Clinical Trials Manager at Bristol Myers Squibb, you will play a critical role in bringing life-changing treatments to patients worldwide. This role requires a unique blend of clinical expertise, project management skills, and collaboration with cross-functional teams.

Key Responsibilities
  • Coordinate country-level cross-functional teams and act as the main point of contact for the protocol manager and other global study team members.
  • Collaborate with internal roles in country and site feasibility processes, including proposal and validation of country study targets.
  • Develop country-level patient recruitment strategies and risk mitigation plans to ensure study enrolment targets and timelines are met.
  • Lead problem-solving and resolution efforts, including management of risk, contingencies, and issue resolution and escalation to stakeholders.
  • Assess and set up vendors during the study startup period.
  • Participate in Investigator Meetings and prepare necessary materials.
  • Ensure data accuracy and completeness in Clinical Trial Management Systems and eDC vendor systems.
  • Validate study-related materials, including protocols, ICFs, and patient materials.
  • Prepare country-specific documents, such as global country-specific amendments.
  • Prepare materials for Site Initiation Visits.
  • Verify and confirm eTMF completeness at the country and site levels.
  • Review Site Monitoring visit reports, take action within specified timelines, and escalate issues for documentation.
  • Coordinate database locks and query follow-up to ensure timely completion.
  • Maintain inspection readiness for assigned trials within the country and provide support for Health Authority inspections and pre-inspection activities.
  • Develop and implement Corrective Actions/Preventive Actions (CAPA) for country-level audit findings.
  • Lead study team meetings and review/approve payments and patient compensation claims.
  • Manage site relationships, including CRO-related issues.
  • May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs).
  • May perform site closure activities and post-close-out activities.
  • May serve as the point of contact for sites.
  • May support preparations for and obtain approval from local Health Authorities, Ethics Committees, and other relevant instances.

Senior Level Expectations:

  • Engage with Protocol Manager, line management, and/or Head of Clinical Operations to resolve complex issues locally and globally.
  • Provide guidance, lead training, and mentor other team members through informal and formal presentations.

A career at Bristol Myers Squibb offers a unique opportunity to transform patients' lives through science. We strive to foster a culture of diversity, inclusion, and collaboration, where each employee can thrive and grow.

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