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