Senior Specialist, Global Trial Master File

BeOne Medicines

Base: $83,800.00 - $118,800.00 annually; bonus/equ...
Not specified
Trial master file management
Veeva clinical vault etmf proficiency
Gcp and ich regulatory knowledge
BeOne Medicines is seeking a Senior Specialist for their Global Trial Master File (TMF) function, responsible for ensuring TMF quality, compliance, and inspection readiness in clinical research. The ideal candidate should have a strong background in clinical research, excellent communication skills, and be proficient in TMF management processes, particularly using Veeva Clinical Vault

Job Summary

  • The role is responsible for overseeing TMF quality, ensuring inspection readiness, and maintaining compliance with GCP and regulatory requirements.
  • Candidates will lead the development of TMF Plans and Indices while collaborating with study teams to ensure timely and high-quality documentation submission.
  • BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), paid time off, and opportunities for equity awards.

Matching Summary

Match Score: 85

BeOne Medicines is seeking a Senior Specialist for their Global Trial Master File (TMF) function, responsible for ensuring TMF quality, compliance, and inspection readiness in clinical research. The ideal candidate should have a strong background in clinical research, excellent communication skills, and be proficient in TMF management processes, particularly using Veeva Clinical Vault.

Salary

Base: $83,800.00 - $118,800.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness

Skills & Requirements

Must-have

  • Trial Master File management
  • Veeva Clinical Vault eTMF proficiency
  • GCP and ICH regulatory knowledge
  • SOP adherence and compliance oversight
  • Inspection and audit readiness maintenance

Nice-to-have

  • Strong organizational and planning skills
  • Effective internal and external communication
  • Problem-solving and decision-making abilities
  • Collaborative team spirit
  • Process optimization experience

Key Requirements

  • 4 years' experience in clinical research environment
  • Trained in ICH, GCP, and local regulations
  • U.S.-based candidate eligibility required

Work Rights

Must be U.S.-based

Tailored Resume

Cover Letter