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