Clinical Trial Administrator

New Today

Direct message the job poster from TMC Pharma Services Ltd

The role of the Senior Clinical Trial Administrator (Sr CTA) 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

Seniority level

Seniority level
Associate

Employment type

Employment type
Full-time

Job function

Job function
Research, Administrative, and Project Management

Referrals increase your chances of interviewing at TMC Pharma Services Ltd by 2x

Get notified about new Clinical Trial Administrator jobs in Hartley Wintney, England, United Kingdom.

Reading, England, United Kingdom 4 days ago

Basingstoke, England, United Kingdom 14 hours ago

Bracknell, England, United Kingdom 14 hours ago

Bracknell, England, United Kingdom 16 hours ago

Basingstoke, England, United Kingdom 16 hours ago