Delivery of site activation readiness within assigned country/sites and risk mitigation.
Prepare Clinical Trial Applications and submission dossiers per local requirements.
Interact with CA/EC for study purposes and responses.
Maintain project plans, trackers and regulatory intelligence tools.
Customize country/site Patient Information Sheets and Informed Consent Forms.
Coordinate translations of documents and maintain TMF readiness.

🎯 Requirements

Bachelor’s degree in life sciences or RN or equivalent.
Pharmacy qualification beneficial.
1+ year regulatory or start-up experience in CRO/pharma.
Strong communication and organizational skills.
Experience with computerized information systems, spreadsheets, word processing and email.
English fluency.

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