(Fw591) Tmf Associate - Spanish Speaking

LOCATION: CORK, IRELAND (funded relocation)

EU/UK Passport required

Responsibilities:

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).
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; and Proficiency with MSOffice
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, Permanent
Salary: 35,000.00€ - 55,000.00€ per year
Ability to commute/relocate: Madrid, Madrid provincia: Reliably commute or willing to relocate with an employer-provided relocation package (required)
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