Location: Cork, Ireland (funded relocation package 2000 EUR + 2 weeks paid accommodation) + great benefits and salary

Required: EU Passport

The Associate role - TMF Projects is part of the Trial Master File Project Team in GBS Cork and is a key partner across Clinical Capabilities which serves as a key role for the execution of TMF Operations processes and administration. Provides process support for TMF creation, maintenance, closure, and archival. Provides support for TMF Operations to resolve any issues identified with the TMF activities. Works with study teams and functions to help mitigate issues, identify the impact on applicable internal processes, and support process improvements. Executes change management oversight to ensure consistent application of revised standards, processes, and systems functionality across study teams. The TMF Project Management Associate will ensure the TMF for the clinical trial(s) are inspection ready through a complete, accurate, and readily available Trial Master File. 

TMF Expertise

• 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 (e.g., a table of contents based on the trial-specific TMF Expected Document Lists (EDLs).
• Assists TMF Process Specialist with 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.

• Collaborate and influence functional representatives and record owners to ensure TMF remains complete, current, and correct.
• Identify opportunities to share learning to the functions as appropriate.
• Support integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices.

 Clinical Trial Essential Document Responsibilities

• Evaluate and tailor the expected documents (ED) to ensure proper tailoring has been assessed to make a trial-specific TMF.
• 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.
• Identify, communicate, and resolve issues.
• Ensure appropriate functional check oversight activities occur for all functional areas.
• Ensure appropriate archiving of clinical trial documents to meet companies’ record retention policies and regulatory requirements.
• Understand, comply, and reinforce local regulations and guidance, Organisation’s medical policies and procedures, and good clinical practices (GCP)
• Ensure inspection readiness through a complete, accurate, and readily available Trial Master File

Minimum Qualification Requirements:

• 1-2 years 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
• Strong written and verbal communication skills; and Proficiency with MS Office/Adobe Acrobat
• Experience in working with electronic trial master files strongly preferred
• Demonstrated critical thinking capabilities with a forward-looking perspective and comfort with ambiguity.

Language Requirements:

• Day-to-day proficiency in Danish

Additional Preferences:

• 1-2 years TMF experience a plus
• Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired
• Ability to learn and comply with regulatory requirements and internal policies​