Clinical Study Administrator (CTA) – Clinical Trials Support

About the role

The Clinical Study Administrator (CTA) provides essential administrative support throughout the lifecycle of clinical studies, from start‑up to close‑out. Working closely with investigators, CROs, and internal teams, the CTA ensures that study documentation is complete, compliant, and ready for regulatory inspection.

Key responsibilities

• Coordinate and administer clinical studies, handling document collection, preparation, review, and tracking.
• Submit applications and supporting documents to EC/IRB and regulatory authorities in a timely manner.
• Maintain the local electronic Trial Master File (eTMF) and Investigator Site File (ISF) according to ICH‑GCP and local requirements.
• Upload and archive essential documents to keep the eTMF inspection‑ready.
• Create and import regulatory documents into the global electronic management system (e.g., ANGEL) following the Authoring Guide.
• Support electronic submissions using Submission Ready Standards (SRS) and manage tracking tools such as CTMS (VCV) and SharePoint.
• Assist with site contract preparation, HCO/HCP payments, and coordination of study materials and equipment.
• Organise internal and external meetings, prepare presentation materials, and ensure accurate layout, language control, and distribution of documents.

Required profile

• Strong understanding of clinical trial processes and ICH‑GCP guidelines.
• Experience working with investigators, CROs, and internal study teams.
• Excellent attention to detail and ability to manage multiple document streams.
• Proactive communication skills for liaising with internal and external stakeholders.

Required skills

• eTMF and ISF management
• Knowledge of ICH‑GCP and local regulatory requirements
• Use of global electronic management systems (e.g., ANGEL)
• CTMS platforms (e.g., VCV) and SharePoint
• Submission Ready Standards (SRS) for regulatory submissions