Related skills
gcp ctms 21 cfr part 11 trial master file siv📋 Description
- Lead and manage CRA team overseeing site monitoring.
- Hire/onboard staff; provide onboarding, training, and access.
- Allocate resources; monitor workload; approve timesheets.
- Ensure monitoring aligns with contract/SOPs; review metrics.
- Coordinate sponsor/client meetings; support submissions and audits.
- Travel to Tempe, AZ for meetings/visits as needed.
🎯 Requirements
- Bachelor's degree in biomedical-related field or life sciences.
- 5+ years in clinical operations; 3+ years onsite monitoring (CRO/Pharma).
- People management experience.
- Excellent English communication; strong organizational and multitasking skills.
- Proficient knowledge of GCP and 21 CFR Part 11.
- Willingness to travel; reside near Tempe, AZ.
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