Clinical Trial Project Lead

5 days ago

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

Transforming Patients' Lives through Science

Bristol Myers Squibb is a leading biopharmaceutical company dedicated to discovering and delivering innovative medicines that help patients overcome life-threatening diseases.

We are seeking a highly skilled Clinical Trial Project Lead to join our team. As a key member of our clinical operations team, you will play a crucial role in the successful execution of clinical trials across various therapeutic areas.

Key Responsibilities:

  • Coordinate country-level cross-functional teams and serve as the primary point of contact for protocol managers and global study team members.
  • Collaborate with internal stakeholders to ensure seamless site feasibility processes, including proposal validation and country study target coordination.
  • Develop and implement country-level patient recruitment strategies, mitigating risks and ensuring timely enrollment targets are met.
  • Lead problem-solving efforts, manage risk, and escalate issues to relevant stakeholders as needed.
  • Assess and establish vendor relationships during study startup periods.
  • Participate in investigator meetings and prepare necessary materials.
  • Maintain accurate data entry in Clinical Trial Management Systems and ensure access to eDC and vendor systems for country and site personnel.
  • Validate study-related materials, including protocols, ICFs, and patient materials.
  • Prepare country-specific documents, such as global country-specific amendments.
  • Coordinate Site Initiation Visits and ensure timely completion of associated tasks.
  • Verify and confirm eTMF completeness at the country and site levels.
  • Review Site Monitoring visit reports, take action within specified timelines, and escalate issues as necessary.
  • Coordinate database locks and query follow-up, ensuring timely completion.
  • Ensure 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 (CAPAs) for country audit findings, driving review, implementation, and completion.
  • Lead local study team meetings and conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs).
  • Perform site closure activities, including post-close-out, and act as the primary point of contact for sites.
  • Support preparing submissions to and obtaining 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.
  • Serve as a key resource for colleagues, providing guidance, leading training, and mentoring team members through informal and formal presentations.

Why Join Us?

At Bristol Myers Squibb, we offer a dynamic work environment that fosters innovation, collaboration, and growth. Our employees are passionate about transforming patients' lives through science, and we strive to create an inclusive culture that promotes diversity, equity, and inclusion.

On-site Protocol:

BMS has a diverse occupancy structure that determines where employees are required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type assigned is determined by the nature and responsibilities of the role.

Compensation and Benefits:

As a Clinical Trial Project Lead at Bristol Myers Squibb, you can expect a competitive salary range of $120,000 - $180,000 per year, depending on location and experience. In addition to a comprehensive compensation package, you will also enjoy a range of benefits, including health insurance, retirement savings plans, paid time off, and opportunities for professional development and growth.

Becoming a Part of Our Team:

To be considered for this exciting opportunity, please submit your application. We look forward to reviewing your qualifications and discussing how you can contribute to our mission of transforming patients' lives through science.

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