BioTalent

Clinical Trial Administrator

Posted: 22 minutes ago

Job Description

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 ResponsibilitiesAdministrative 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.QualificationsRequired: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 Skills2+ 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).

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