Skills

Research Training GCP

Job Specifications

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).

About the Company

We are BioTalent, the life sciences recruitment specialists with the means to nurture change-makers. Our expert consultants focus on Medical Communications, Healthcare Advertising and public Relations, Market Access, Research and development, Data Science & AI, Clinical, Regulatory, Engineering & CQV, Manufacturing & Operation, Quality, Medical and Drug Safety, and Commercial. We have a global reach, with offices in the UK (London), Switzerland (Zug), and the USA (New York, San Diego, Miami and Boston). We are part of T... Know more