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TMF Projects Associate - French

Reference:AOORAAPH-248863 Location: Cork
Cork City
Qualification:DegreeExperience:0-1 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Data Management

TMF Projects – French or Polish Speaking

Core Competencies:

  1. Clinical/ Pharmaceutical experience
  2. Document Management experience
  3. Native/ Fluent French or Polish

The TMF Projects Associate/Sr. Associate/Manager serves as a key role for the execution of TMF operations, processes and administration. The role will be based in the Global Business Solutions (GBS) center in Cork, with daily functional interactions with the wider team in the US. The role provides process support for TMF creation, maintenance, closure and archival. The role also provides support for TMF Operations to resolve any issues identified with the TMF activities. The TMF Projects Associate/Sr. Associate/Manager works with study teams and functions to help mitigate issues, identify impact to applicable internal processes and support process improvements. The role will execute change management oversight to ensure consistent application of revised standards, processes, and systems functionality across study teams. The TMF Projects Associate/Sr. Associate/Manager will ensure the TMF for the clinical trial(s) are inspection ready through a complete, accurate and readily available Trial Master File. Additional country specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Primary Responsibilities

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.
  • Provide support to ongoing and ad-hoc TMF projects and initiatives.

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 the company’s record retention policies and regulatory requirements.
  • Understand, comply, and reinforce local regulations and guidance, company 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
  • Day-to-day proficiency in one or more of the following language: French.
  • Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development, preferred.
  • 0-2 years’ experience with clinical development processes, preferred
  • Experience in document administration.
  • Knowledge of cGCP.

Other Information/Additional Preferences
  • 1-2 years TMF experience.
  • Experience in working with electronic trial master files strongly preferred.
  • 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.

For further information please contact Alan on / +353 87 365 7522