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

A leading clinical research services provider in England is seeking an experienced administrative support professional for a hybrid role in Fleet. The successful candidate will assist the Project Manager(s) and clinical trial teams, maintaining the Trial Master File and supporting various administrative tasks. Applicants should have a minimum of 3-5 years of administrative experience and be fluent in English. This role offers a dynamic environment where attention to detail and strong organizational skills are crucial.