Global Clinical Trial Manager | Start-Up & Site Lead

Bristol Myers Squibb

United States

On-site

USD 104,000 - 125,000

Full time

2 days ago
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Benefits offered by this job

Flexible Time Off
Comprehensive benefits
Generous holidays

Job summary

Bristol Myers Squibb seeks a Clinical Trial Manager to coordinate country-level trial start-up activities, liaise with global study teams, and ensure regulatory submissions and data integrity across CTMS/eTMF systems. The role emphasizes collaboration, risk management, and site readiness to advance clinical research programs.

The ideal candidate has 4+ years in clinical research, strong GCP/ICH knowledge, and experience guiding cross-functional teams through regulatory processes.

Qualifications

  • Bachelor's or Master's degree required. Field of study within life sciences or equivalent
  • Minimum of 4 years' industry related experience
  • Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
  • Serve as a Subject Matter Expert (SME) with mentoring responsibilities
  • Travel Required (Occasional local travel < 1 month/quarter)

Responsibilities

  • Acts as main contact for a country with global study team coordination.
  • Implements country-level feasibility process with leadership endorsement.
  • Plans timelines for start-up with GTAC and stakeholders.
  • Manages country-level patient recruitment strategy and risk mitigation.
  • Leads problem solving and escalation with appropriate stakeholders.
  • Ensures CTMS/eTMF data is current and accessible.
  • Prepares Investigator Site materials and site initiation support.
  • Coordinates regulatory submissions to Health Authorities and Ethics Committees.

Skills

GCP knowledge
ICH guidelines
Cross-functional teamwork
Regulatory knowledge
CTMS familiarity
eTMF familiarity
eDC familiarity
Microsoft Office

Education

Bachelor's or Master's in life sciences

Tools

CTMS
eDC
eTMF
Microsoft Office

Job description

Bristol Myers Squibb seeks a Clinical Trial Manager to coordinate country-level trial start-up activities, liaise with global study teams, and ensure regulatory submissions and data integrity across CTMS/eTMF systems. The role emphasizes collaboration, risk management, and site readiness to advance clinical research programs.

The ideal candidate has 4+ years in clinical research, strong GCP/ICH knowledge, and experience guiding cross-functional teams through regulatory processes.

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