Document Specialist

3 months ago

Worthing, United Kingdom Allergy Therapeutics Full time

Department: Clinical Science & Operations
Hours per week: 37.5

Basis: Permanent

**Job Purpose
The Document Specialist will provide primary support to ensure the overall health of the Allergy Therapeutics
Trial Master Files (TMFs). The Document Specialist will deliver technical expertise in the Trial Master File
(paper TMF and electronic TMF) management and will provide support to assigned clinical trials throughout
the lifecycle of the trial.

**Key Responsibilities
- Perform quality control checks of study documents prior to upload in the study-specific

eTMF; revert to document owner for any issues noted and track resolution
- Retrieve, file and upload assigned documents into Montrium eTMF in accordance with

applicable SOPs, policies, and system requirements
- Participate in scheduled quality checks/reviews of eTMF
- Create and/or maintains any general document/file-related tracking forms and/or spreadsheets,

as applicable
- Complete Montrium eTMF training to comply with all regulations as instructed by management,

the Quality Department, or as per the ICH-GCP Guideline

**Knowledge, Experience & Skills Required
- Document management experience, with experience working with an eTMF system
- Proficient user of Microsoft Office (Outlook, Word and Excel)
- Strong organisational, interpersonal and influencing skills
- Knowledge and understanding of Good Clinical practice and applicable regulatory environment

would be beneficial

If you are interested in this role,
a job description is available on request.

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