Country Study Start Up Senior Specialist
AbbVie · Cdmx, Mexico
Clinical OperationsFull timeCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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