Related skills
gcp project management milestone_tracking_tools irb_ethics_submissions📋 Description
- Manage site start-up process and activation readiness
- Plan and track IRB/EC, CA/MoH, ICF customization, and contracts
- Align milestones with stakeholders for timely site activation
- Lead client meetings on expectations, risks, and metrics
- Mentor staff; train on country start-up procedures
- Translate and coordinate submission documents; ensure accuracy
🎯 Requirements
- Bachelor's degree in life sciences or RN, or equivalent
- 5+ years in start-up or PM in CRO/pharma
- 2+ years milestone mgmt, budgets, and coordinating teams
- Strong leadership and cross-functional collaboration
- Excellent communication in English; local language for non-English countries
- Knowledge of GCP/ICH guidelines and regulatory requirements
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