eTMF Specialist

<h2>Job Overview:</h2><ul><li style="margin: 0in 0in .0001pt .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Perform eTMF periodic Review of documents for Content & Completeness check </span></li><li style="margin: 0in 0in .0001pt .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Perform eTMF Reconciliation tasks (Missing document, duplicates identification etc)</span></li><li style="margin: 0in 0in .0001pt .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Follow with action owners for Open TMF Issues</span></li><li style="margin: 0in 0in .0001pt .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Maintain the eTMF in state of Inspection Readiness</span></li><li style="margin: 0in 0in .0001pt .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Ensure eTMF is always audit ready</span></li><li style="margin: 0in 0in .0001pt .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Review and respond to TMF content quality issues and identifies trends per study and across programs; alerts management of trends</span></li><li style="margin: 0in 0in .0001pt .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Compliance to TMF Completeness, TMF Reviews & TMF Issue Resolutions</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Commitment to continuous improvement of TMF delivery</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Driving a culture of Inspection Readiness</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Creating a seamless TMF delivery process</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;">Associates - 4 Years with Degree in Life science</p><p style="margin: 0px;">4+years with relevant skill - eTMF Periodic Review and/or CRA/Monitoring skills</p><h2>Experience:</h2><ul><li>Minimum 4 years' experience working in a clinical research environment.</li><li>Understanding of GCP and ICH guidelines.</li><li>Knowledge of Regulatory/Clinical document requirements.</li><li>Extensive experience working in clinical electronic systems.</li><li>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.</li><li>Excellent interpersonal skills.</li></ul>