Trial Master File Lead

Permanent | Warsaw, INDIANA | 11 days

Job Summary


Job Description

If you have an extensive experience interpreting clinical trial protocols for the purpose of establishing and designing the documentation requirements within Trial Master File system, learn more about how you can be a part of ICON's Trial Master File Operations group that's responsible for verifying clinical trial documentation is consistent with the TMF specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.

About the Trial Master File Lead role within ICON:

  • The Trial Master File Lead will play a key role in developing and assisting with the implementation of TMF specifications, ensuring they are in alignment with the program strategy and milestones.
  • Assess the impact of potential changes to TMF specifications prior to implementation and collaborate with Sponsor Teams as appropriate. Serve as the single point of contact for functional team members and clients related to TMF processes and activities.
  • Under the supervision of the TMF Operations Leadership team, the Trial Master File Owner/Lead will assist with responses to regulatory authorities/inspectors with regard to documentation management activities for audits, questions, and issues.
  • The Trial Master File Lead will regularly review metrics established for performance, review data quality outputs and audit outputs to identify trends per study and across programs, and assist with the development of corrective action plans related to TMF findings.
  • The Trial Master File Lead will review the processes to actively identify continuous improvement opportunities and enhance operational efficiency. Working in a professional and employee friendly environment, the TMF Lead will frequently communicate within both internal and external clients in a professional manner.

To succeed you will need:

  • Bachelor's Degree is required along with significant experience in Clinical Operations/Documentation Management/Clinical Research industry experience.
  • You will require TMF and industry experience to understand the processes and documents required within the conduct of clinical trials.
  • You will have good organizational and negotiation skills, the ability to manage multiple tasks and proven experience of high standards of attention to detail.
  • You will possess good written and verbal communication skills with global projects/team exposure. Project Management and Quality Assurance experience will be an added advantage
  • Competent computer skills - MS Outlook, PPT, Excel and experience with electronic document management systems preferred."