Senior/Clinical Trial Administrator

The Senior Clinical Trial Administrator will provide daily operational and administrative support to Project Managers, Project Directors, and cross-functional study teams. This role focuses on ensuring the completeness, quality, and inspection-readiness of the Trial Master File (TMF/eTMF). The position also supports the Project Support function in setting up and archiving electronic TMFs. This position is a 3 month contract that will turn into a permanent position.

Hybrid Working:

The role requires 1–2 days a week in the office initially to integrate with the team.

Key Responsibilities

• Administrative Support: Assist clinical project teams throughout study planning, initiation, execution, and close-out, following ICH-GCP, internal procedures, and regulatory standards.
• TMF Oversight: Maintain, update, and quality-check TMF/eTMF content to ensure continuous inspection readiness.
• CTMS Management: Handle data entry, updates, and reporting within the Clinical Trial Management System.
• Document Tracking: Monitor study documents, essential correspondence, and contractual records.
• Study Materials: Prepare and review site documentation, trackers, and meeting minutes.
• Training Coordination: Manage study-specific training assignments in the Learning Management System.
• Audit/Inspection Support: Assist with document retrieval, QC checks, and audit preparation.
• Team Support: Offer guidance to junior administrative staff or CTAs as needed.

Qualifications

Required:

• Relevant professional experience or secondary-level education (equivalent to high school).
• Fluent written and spoken English.

Preferred:

• Degree in a life-science field or equivalent.
• Clinical research qualification.

Experience & Technical Skills

• 2+ years’ administrative experience or equivalent training.
• At least 2 years working in clinical research.
• Solid understanding of GCP (E6 R3).
• Knowledge of clinical trial documentation standards.
• Experience with clinical trial management systems (CTMS/eTMF).
• Basic understanding of the clinical trial lifecycle.
• Proficient with MS Office (Word, Excel, PowerPoint, Outlook).