Clinical Study Administrator

Responsibilities

• Coordinate study activities from start-up to execution and close-out within Country Operations Management
• Manage end-to-end electronic Trial Master File (eTMF) set-up and maintenance
• Track regulatory documents, team training, and milestones in the Clinical Trial Management System (CTMS)
• Support start-up activities including CDA delivery, negotiation, and site file preparation
• Collaborate with study vendors on clinical trial supplies and tracking
• Act as a central point of contact for project communications and documentation
• Assist with local language translations and IRB/CEC/CA submissions
• Support local F2F study meetings and team teleconferences

Requirements

• Bachelor's Degree in a related discipline, preferably life science
• Excellent written and verbal communication skills in English and local language
• Proficiency with MS Office Suite (Excel, Word, PowerPoint)
• Understanding of the drug development process
• Strong organizational skills and attention to detail
• Ability to manage competing priorities

Preferred Qualifications

• Prior experience working in clinical research
• Medical knowledge in rare disease areas
• Experience working in a matrix reporting structure
• Ability to champion efficient processes to reduce budget and time
• Proficiency in using digital systems and software in an e-enabled environment

About the Company

AstraZeneca is a forward-thinking BioPharmaceutical company dedicated to delivering life-changing medicines. Their rare diseases division offers an entrepreneurial environment backed by the stability of a global pharma leader.