Connecting Talent to opportunity

Connecting Talent to opportunity

TMF Associate - Spanish speaking

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Job Description:

***LOCATION: CORK, IRELAND 

***EU/UK Passport required

Responsibilities:

· 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)

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 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 Type

    Permanent, Full Time

  • Work Authorisation

    No

  • Industry Sector Other

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