Senior Clinical Trial Administrator (Sr CTA)

Fleet, Hampshire
TMC Pharma Services Ltd

The role is to perform daily administrative activities and support the Project Manager(s), Project Director(s) and cross-functional study team(s) through expert knowledge and effective use of the systems, tools and processes available with a focus on a complete and accurate Trial Master File (TMF) delivery. Supports Project Support Specialist (PSS) in setting up and archiving eTMF(s).

THIS IS A HYBRID ROLE: WE EXPECT THE SUCCESSFUL CANDIDATE TO WORK IN THE OFFICE 2-3 DAYS PER WEEK

Specific Duties:

• Administrative Support to the Project team: Support clinical trial teams in the planning, initiation, execution, and close out of studies in compliance with ICH GCP, SOPs, and regulatory requirements.
• TMF Management: Maintain and update the Trial Master File (TMF/eTMF) to ensure inspection readiness at all times. –
• CPTMS Management: Manage and support the Clinical Trial Management System (CTMS), ensuring accurate and timely data entry, updates, and reporting.
• Project Tracking: Coordinate and track study documents, contracts, and essential trial correspondence.
• Assist with the preparation and review of study related materials, including site binders, tracking logs, and meeting minutes.
• Coordination of study specific training in the Learning Management System (LMS)
• Support preparation for audits and inspections, including document retrieval and QC checks.
• Provide mentorship and guidance to junior Clinical Trial Assistants or administrative staff.

Person Specification:

• Exceptional interpersonal skills to work to work with sites, TMC employees and other associates.
• First class administrative and organisational skills.
• Proactive approach to work, demonstrating initiative and reliability.
• High standard of written and spoken English, with a keen eye for detail.
• Outstanding work ethic and commitment to meeting timelines without compromising quality.

Education and Qualifications:

Required:

• Either relevant work experience or High School Diploma (or equivalent)
• Fluent in English to business level
• And/or a Qualification in clinical research

Specific Knowledge, Experience and Technical Skills:

• 3-5 years of administrative support experience or equivalent combination of education, training and experience
• Minimum 2 years clinical research experience
• Good working knowledge of GCP E6 R3
• Good knowledge of clinical trial documentation
• Able to use clinical trial management systems
• Basic understanding of the clinical trial process and lifecycle