Oversees all aspects of study site management to protect patient safety and data quality.
Ensures audit readiness and supports IRB/EC submissions and audits.
Manages site startup activities including feasibility, regulatory documents, and IP prep.
Conducts pre-study, initiation, monitoring, and close-out visits with timely reports.
Verifies informed consent and data integrity; manages SAE and safety issues.
Maintains trial tools, ISF/TMF, data reviews, and IP inventory.

🎯 Requirements

Bachelor's degree or international equivalent.
3+ years on-site monitoring experience; oncology/Phase I preferred.
Proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Fluent English; strong interpersonal and organizational skills.
Working knowledge of the drug development process; travel 60-70%.
Ability to work effectively in a remote environment.

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