***LOCATION: CORK, IRELAND
***EU/UK Passport required
· Serve as TMF subject matter expert.
· 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.
· Handles 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)
· 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; and 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
Permanent, Full Time
- Industry Sector Other