Centralized Study Specialist II (eTMF)

Job Overview:Perform eTMF periodic Review of documents for Content & Completeness check Perform eTMF Reconciliation tasks (Missing document, duplicates identification etc) Follow with action owners for Open TMF Issues Maintain the eTMF in state of Inspection Readiness Ensure eTMF is always audit ready Review and respond to TMF content quality issues and identifies trends per study and across programs; alerts management of trends Compliance to TMF Completeness, TMF Reviews & TMF Issue Resolutions Commitment to continuous improvement of TMF delivery Driving a culture of Inspection Readiness Creating a seamless TMF delivery process Education/Qualifications:

Associates - 4 Years with Degree in Life science

4+years with relevant skill - eTMF periodic review or Monitoring skillsExperience:

Minimum Required:Minimum 4 years' experience working in a clinical research environment.Understanding of GCP and ICH guidelines.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.