Senior Specialist, Country Study Start Up
AbbVieShanghaiFull TimeHealthcare
Remotely
gcpregulatory affairsirbichixrsicfvault ssu
Job Description
📋 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.
🎯 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.
🎁 Benefits
- AbbVie equal opportunity employer.
- Global career opportunities in Immunology, Oncology, Neuroscience.