Senior Clinical Trial Administrator
3 days ago
Hook
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), • 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
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