Senior Specialist, Country Study Start Up

Added
23 hours ago
Type
Full time
Salary
Salary not provided

Related skills

gcp regulatory affairs ich ixrs irb

๐Ÿ“‹ Description

  • Lead start-up and maintenance activities for sites and studies in assigned country/countries.
  • Ensure on-time, budget, and quality delivery with cross-functional teams.
  • Provide SME support, training, and change management for new tech/process adoption.
  • Support Country SSU leadership to improve cycle times and performance metrics.
  • Coordinate with Regulatory/CTS, Contract Manager, Site Monitor, and CSM Leads for activation
  • Drive process improvements to enhance site start-up efficiency.

๐ŸŽฏ Requirements

  • Bachelor's Degree (health care or scientific field) preferred or equivalent experience.
  • Minimum 3 years of clinical research experience; 2+ years in study start up management (region).
  • Experience with central/local IRB/EC, ICF review, and regulatory routing.
  • Proficient with Vault SSU for essential docs, IP release, and IP shipments.
  • Strong analytical and multitasking abilities in fast-paced settings.
  • Knowledge of ICH and GCP guidelines and country regulatory environment.

๐ŸŽ Benefits

  • AbbVie equal opportunity employer.
  • Global career opportunities in Immunology, Oncology, Neuroscience.
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