Trial Master File Owner

If you have experience interpreting clinical trial protocols for the purpose of establishing and designing documentation requirements for a Trial Master File system, learn more about how you can be a part of ICON’s Document Management 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 Owner role within ICON: 

The Trial Master File Owner will work with Project Managers to setup the Trial Master File for each study to meet client needs and serve as a resource in maintaining the inspection-readiness of a protocol throughout the life of the trial. 

The Trial Master File Owner will support study teams in meeting the sponsor’s standards of quality, by maintaining the accuracy of the TMF through study team meetings and communications, generating reports to measure TMF performance, enforcing document due dates and proactively providing feedback to teams in terms of how the quality and timeliness of submissions can be improved through analyzed trends. The Trial Master File Owner will also assist with internal and external audits.

Benefits of working at ICON:

We provide our Trial Master File Owner with the resources to be successful in supporting their line of business. In addition, we offer a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and an annual incentive plan to reward performance.  

To succeed you will need:

Bachelor’s Degree or local equivalent is preferred.  You will possess a High School diploma, or local equivalent and a minimum of one year experience and/or understanding of clinical study start up requirements and activities.  You will have good organizational 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 and have logical and critical thinking skills.  Competent computer skills – MS Outlook and Excel.

We invite you to review our opportunities at www.iconplc.com/careers.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

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