Trial Master file Owner

Trial Master File Owner

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

Overview of the Role

• You will be responsible to ensure a complete and accurate Trial Master File through documentation quality and consistency across programs.
• You will determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
• You will assess impact of potential changes to TMF specifications prior to implementation and collaborating with CPM if modifications are necessary.
• You will review audit reports and document metrics for trends and to ensure that program document management deliverables are on target.
• You will serve as a point of contact for providing responses to regulatory authorities with regard to documentation management activities for audits, regulatory submission issues and product defense.

Role Requirements

• You will possess a Bachelor’s Degree or equivalent degree/experience.
• You must have clinical documentation management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
• You must have project management, resource management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• You must have experience supporting regulatory submissions and inspections preferred.   Strong skills in negotiation and conflict resolution essential too.  

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  Your dedicated recruiter will discuss this information with you during your phone interview.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

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.