AbbVie seeks a Senior Specialist to lead clinical study startup and maintenance activities across assigned sites and countries. The role involves coordinating regulatory approvals, managing site activation timelines, and mentoring junior specialists while driving process improvements in startup efficiency.
Responsibilities
Execute on-time, budget-compliant startup and maintenance activities for assigned sites and studies
Establish country and site activation plans with risk assessment and mitigation strategies
Coordinate regulatory submissions, IRB/EC approvals, and clinical supply shipments
Maintain startup performance metrics and databases; provide regular updates to leadership
Mentor Country Start-Up Specialists and lead process improvement and change management initiatives
Requirements




Bachelor's degree in healthcare or scientific field, or equivalent experience
Minimum 3 years clinical research experience with 2+ years study startup management
Hands-on experience interpreting regional clinical research regulations and processes
Demonstrated proficiency with Vault SSU for essential documents, IP release, and ICF review
Working knowledge of ICH and GCP guidelines and local regulatory environment
Strong analytical and critical thinking skills with ability to manage multiple priorities
Experience leading initiatives and mentoring junior staff in fast-paced environments

📌 Country Study Start Up Senior Specialist (Xico)
🏢 Abbvie
📍 Xico