Senior TMF Lead

If you have extensive 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 Senior Trial Master File Owner role within ICON: 

The Senior Trial Master File Owner will play a key role in developing and assisting with the implementation of TMF specifications, ensuring TMF specifications are in alignment with the program strategy and milestones, and serve as the point of contact for internal and external audits related to TMF processes and activities.

Under the supervision of the Document Management Director the Senior Trial Master File Owner will assist with responses to regulatory authorities with regard to documentation management activities for audits, questions, and issues.  The Senior Trial Master File Owner will 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.

Benefits of working at ICON:

We provide our Senior 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 is required along with a minimum of three years’ experience and understanding of clinical study start up requirements and activities. 

You will require Clinical Document Management and industry experience to understand the processes and documents required within the conduct of clinical trials.  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 and experience with electronic document management systems preferred.

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 - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment