eTMF Specialist (Electronic Document Management)

Maidenhead, United Kingdom
30 Apr 2021
24 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Covance are looking to hire an eTMF Specialist, working on an initial 12 month fixed-term contract (directly employed by Covance).

The eTMF Specialist m anages the set up and maintenance of electronic Trial Master Files (eTMF), Trial, Country and Site artifacts for clinical studies in support of sponsors services contracts and internal Covance business needs. You will be managing both paper and electric clinical trial documents.

Great opportunity to start your career in Clinical Research!

Please note: This position is based at our office in Maidenhead.

In this position you will provide process, control, coordination, and approval of clinical trial documents. This position is responsible for managing Phase I-IV clinical trial electronic trial master files (eTMF). Support and training will be provided, as required.

Responsibilities include:
  • Maintains an understanding of applicable regulatory requirements.
  • Manages the set up and maintenance of electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Project Manager.
  • Leads the development, creates and maintains of the eTMF Plan and. TMF Index with Project Manager/Study Lead and/or sponsors.
  • Responsible for mapping the sponsors TMF Index, if applicable, to the Covance TMF Index and adds/modifies all approved TMF artifacts in the Covance TMF Index, according to Covance SOP's, and/or sponsor SOP's.
  • Maintains the TMF in a state of audit readiness for quality and compliance by:
  • Visual quality checks of e-documents prior to release to confirm image clarity and readability.
  • Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate;
  • Initiating the What's Missing for all documents and ensuring full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and study milestones.
    • Comply with metrics established for performance TMF reviews.
    • Process and track final essential artifacts required throughout all phases of the study in accordance with Covance SOPs, sponsor SOPs, GCP and ICH guidelines.
    • Manages the identification of operational and logistical issues and resolutions related to the TMF.
    • Responsible for gathering data requested by study team to support status reports to clients.
    Degree preferrable.
    Knowledge and an interest in clinical research would be strongly desirable. This is a great opportunty to work in clinical research
    • Excellent administration and organisation skills required, as well as strong and attention to detail.
    • Good knowledge of Microsoft Office products, web based applications, and Adobe Acrobat.
    • Excellent interpersonal skills.
    • Knowledge of Regulatory/Clinical documents would be an advantage
    • Experience working in clinical electronic systems / eTMF woluld be desirable.
    • Industry experience would be beneficial