Due to expansion TMC are looking to hire a Senior Clinical Trial Administrator (Sr CTA).
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
Desirable
* Degree-level qualification in a life-science discipline or equivalent
* 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
Computer literacy: e.g., Microsoft Word, Excel, PowerPoint, Outlook