TMF Specialist I / II

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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.

As a TMF Specialist I /II you will complete Document Management activities in support of client services contracts and internal ICON business needs.

Location:

• Warsaw / Poland (Office-based)

Key responsibilities:

• Process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable.
• Liaise with study teams and other Document Management staff in order to fulfill job responsibilities and activities.
• Complete departmental projects as assigned in accordance with specified timelines, ICON SOPs/WPs and regulations.
• Maintain study files as per study and/or client requirements or in accordance with ICON SOPs/WPs and applicable regulations.
• Complete activities related to document receipt and processing which may include but is not limited to:  document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
• Provide information necessary to complete client and/or departmental status reports as requested by the management of the Document Management department.
• Inform the Manager of training issues, project activities, quality issues and timelines as directed.
• Provide copies of study documents to ICON or client personnel as requested.
• Participate in client and/or ICON audits and document archiving activities as necessary.
• Participate in training related to fulfilment of responsibilities as required by ICON and/or the client.
• Liaise with Clients, as appropriate, on project issues when directed by the Manager.
• Handle special projects or duties as requested by the Manager. 

Role Requirements: 

• TMF (Trial Master File) experience and knowledge of Clinical Studies documents would be an advantage
• Ability to successfully liaise with study project teams, staff, clients and management, as necessary.
• Good oral and written communication skills and interpersonal skills. 
• Competent computer skills.

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.