Trial Initiation Specialist (TIS)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. 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.

What will you be doing?

The Trial Initiation Specialist will create Investigator budgets utilizing available protocol information and the Fair Market Value System. The budgets created will support both the Proposals group for the Bid defense process as well as the Contracts team for post-award work. 

What do you need to have?

• Responsible for the development of fair market value for investigator and site fees, according to industry pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information on a Global project scale
• Provide training on group function and processes as appropriate
• Maintain database of information related to pricing that includes, Standard of Care, Bench Marking data and Fair Market Value figures
• Provide guidance to clinical teams and departmental staff on fair market value questions and assessment requests
• Use industry benchmarking pricing tool(s) and internal historical data to create base clinical study budgets
• Apply fair market value and compliance concepts to unique situations and collaborate as appropriate to reach resolution Apply Industry Standard of Care concepts to budget building model Determine potential needs for pricing amendments and redistribution of pricing reports, as appropriate.
• Collaborate with other departments to ensure smooth functioning of processes surrounding re-pricing and pricing scenario requests
• Ensure that per patient and site budgets are in compliance with corporate process, guidelines, and strategies
• Assume responsibility for all aspects of pricing document and metrics tracking including management of compliance documentation and exception justifications to comply with internal policies and audit requirements
• Adhere to SOPs, ethics and departmental compliance
• Work proactively to improve processes and establish refinements that reduce cycle time create savings and improve efficiency in the initiation of clinical trial sites.

• Experience building the clinical budget from the clinical protocl. 
• 2 plus years of experience negotiating site budgets (with sponsor and/or site) preferred.
• 2 plus years of experience creating site budgets.
• Read write and speak fluent English; fluent in host country language required.
• Bachelor’s Degree or international equivalent required.
• One or more years of relevant work experience.
• Excellent written, oral communication and presentation skills; Proficient in Microsoft Excel, Access, and Word

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.