Trial Master File Associate - Ireland - Spanish |

LOCATION: CORK, IRELAND (funded relocation)EU/UK Passport requiredResponsibilities: Partner with internal colleagues to develop and execute metrics to demonstrate control of the TMF process.Support internal audits and external inspections, as appropriate.Providing process and planning support to study teams with TMF-related remediation and process execution as needed.Handle eTMF process-related questions and answers.Provide support with TMF Operations administrative activities such as TMF open office hours, meetings agendas/minutes, etc.Provide support to ongoing and ad-hoc TMF projects and initiatives.Define, manage, and execute TMF implementation plans for the trial from start-up to close-out.Communicate global internal/external requirements as it relates to the TMF during collaborative functional meetings.Evaluate the TMF records prior to finalization, as appropriate.Communicate directly with functional areas for proper hands-off to occur during the start-up, maintenance, and close-out of the trial.Understand, comply and reinforce local regulations and guidance, the company's medical policies and procedures, and good clinical practices (GCP).Qualification Requirements: Proficiency in English and Spanish .Minimum 1 year of experience with clinical development processes.Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable.Experience in document administration.Knowledge of GCP.High attention to detail.Excellent organizational skills.Strong written and verbal communication skills.Proficiency with MS Office.Experience in working with electronic trial master files strongly preferred.Demonstrated critical thinking capabilities with a forward-looking perspective and comfort with ambiguity.Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired.Job Types: Full-time, PermanentSalary: 30,000.00€ - 50,000.00€ per year#J-18808-Ljbffr