Clinical Trial Manager

2 months ago

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

Bristol Myers Squibb is seeking a highly skilled and experienced Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for coordinating country-level clinical trials, ensuring timely and successful execution of study protocols, and collaborating with cross-functional teams to achieve project goals.

Key Responsibilities
  • Coordinate country-level clinical trials, including protocol development, site feasibility, and patient recruitment.
  • Develop and implement country-level patient recruitment strategies and risk mitigation plans.
  • Lead problem-solving and resolution efforts, including management of risk, contingencies, and issue resolution.
  • Assess and set up vendors during study startup periods.
  • Participate in investigator meetings and prepare necessary documents.
  • Ensure data accuracy and completeness in clinical trial management systems.
  • Validate study-related materials, including protocols, informed consent forms, and patient materials.
  • Prepare country-specific documents, including global country-specific amendments.
  • Coordinate site initiation visits and ensure timely completion of study-related tasks.
  • Review site monitoring visit reports, take action, and escalate issues as necessary.
  • Coordinate database locks and query follow-up, ensuring timely completion.
  • Ensure inspection readiness of assigned trials within the country.
  • 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 and site initiation visits.
  • May perform site closure activities, including post-close-out.
  • May act as point of contact for sites.
Senior Level Expectations
  • Engage with protocol manager, line management, and/or head of clinical operations to resolve complex issues locally and globally.
  • Serve as a key resource for colleagues, providing guidance, leading training, and mentoring through informal and/or formal presentations.
About Bristol Myers Squibb

Bristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. Our company is driven by a shared vision to make a meaningful difference in the lives of patients, and we are committed to fostering a culture of innovation, collaboration, and inclusivity.

We are an equal opportunities employer and welcome applications from diverse candidates. We are committed to creating a workplace that is inclusive, respectful, and supportive of all employees. If you require reasonable accommodations or adjustments in completing this application or in any part of the recruitment process, please direct your inquiries to our HR department.

We are dedicated to ensuring that our employees are well-equipped to excel in their roles and contribute to the success of our company. We offer a comprehensive benefits package, including health insurance, retirement plans, and paid time off. We also provide opportunities for professional development and growth, including training programs, mentorship, and career advancement opportunities.

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