Specialist, Country Study Start Up

📋 Description

• Drive and execute start-up and maintenance activities for assigned studies/sites in country(ies).
• Establish activation plans with risk assessment and mitigation in collaboration with
• Collect essential documents, perform QA checks (ALCOA), and coordinate ethics/local packages.
• Coordinate regulatory submissions and alignment with site activation requirements.
• Trigger clinical supply shipments, IP releases, and activar site in IXRS.
• Maintain local intelligence databases, SSU metrics, and audit readiness.

🎯 Requirements

• Bachelor's Degree in health care or scientific field preferred or equivalent experience.
• 1-2 years of clinical research and start-up management experience for designated region.
• Experience with remote/virtual teams; strong interpersonal and communication skills.
• Knowledge of ICH and GCP guidelines and regulatory environments.

🎁 Benefits