Covance are looking to hire a eTMF Specialist on an initial 12 month contract (dierctly employed by Covance) - This position will be based at our office in Maidemhead.
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.
Position provides process, control, coordination, and approval of clinical trial documents. Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).
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.
- 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:
- 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 level preferrable
Experience with working on Trial Master Files would be of benefit.
- Knowledge of Regulatory/Clinical document requirements.
- Extensive experience working in clinical electronic systems.
- Extensive knowledge of Microsoft Office products, web based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.
- Excellent interpersonal skills.
- Knowlege of eTMF would be of benefit