Global Patient Safety (GPS)Trial Master File (TMF) Specialist (Contract)

As a Global Patient Safety (GPS) Trial Master File (TMF) Specialist, you will be the GPS TMF lead in the cross-functional management of TMF for Company’s clinical studies. The responsibilities will include the oversight of GPS vendors to ensure proper collection and filing of all safety documentation into the applicable eTMF platform.Responsibilities:Serve as the GPS TMF lead in the cross-functional management of TMFs for all clinical studiesAdhere to applicable Standard Operating Procedures (SOP), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) Guidelines, and ALCOA+ principlesCommunicate TMF filing status to cross-functional teams to ensure study goals are metCo-author, review, and manage all eTMF Plans, Index, applicable SOPs/guidance documents and associated documents as the GPS subject matter expert (SME)Perform quality control of uploaded documents to ensure accurate uploading and proper indexingEstablish and manage quality oversight of study TMFs, including TMF metrics and KPIsPartner with CROs/vendors and cross-functional team members to manage TMF activities, as neededMaintain vendor and internal processes for cataloging, filing, retrieving, saving and transferring TMF recordsDevelop successful working relationships with CROs/vendors on TMF managementSupport audit and inspections for GPS TMF related activitiesActively contribute in the eTMF uploads for all relevant clinical studies, as neededParticipate in other GPS activities as appropriateRequired Skills, Experience and Education:Bachelor’s degree preferably in biological sciences or health-related field2 years minimum of in depth TMF management experience within Pharmacovigilance/SafetyStrong knowledge and understanding of international safety reporting regulations and safety reporting complianceA Strong working knowledge with the DIA TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standard and regulatory requirements related to document managementProven ability to successfully oversee TMFs including development of relevant processes and policiesThrives in a collaborative team setting that demonstrates flexibility required to maintain a fast paceExcellent written/verbal communication, interpersonal skills and decision-making skillsHigh sense of priority and commitment to excellence in the successful execution of deliverablesProficient in SharePoint and various eTMF platforms such as Veeva, Trial Interactive, WingSpan, FLEXProficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plusTravel may be required, if remote (25%)Preferred Skills, Experience and Education:Experience working with CROs/vendors and management of external resourcesOncology experience, early and/or late stage

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