eTMF Compliance Lead
- Permanent
- Quality Assurance, Auditing
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Hobson Prior are looking for an eTMF Compliance Lead to join a leading pharmaceutical organisation focused on recognising and developing new mechanism antibiotics for the treatment of serious infections. This is a permanent position that can either be based in the US or the UK.
Job Responsibilities:
- Manages the set up and maintenance of electronic Trial Master Files, 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.
- Accountable for mapping the sponsors TMF Index, if applicable, to the organisation's TMF Index and adds/modifies all approved TMF artifacts in the TMF Index, according to organisation's SOP's, and/or sponsor SOP's.
- 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.
- Process and track final essential artifacts required throughout all phases of the study in accordance with the organisation's 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.
- Prepares the TMF for QA or Sponsor audits, leads the resolution with identifying and implementing corrective actions to findings in audit reports.
- Partakes in audits and regulatory inspections by providing guided access to the eTMF study area.
- Perform other related duties as assigned.
Requirements:
- You will have at least 4+ years of Veeva Vault Experience.
- Over 6 years in a GCP field.
Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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