CT SME

Clinical Trail SME (Subject Matter Expert) / In-House CRA

Location: Dublin and/or Limerick

Are you are tired of traveling to client sites? Looking to join a company which will offer you a strong support network and an inspiring working environment, then this is the job for you. Applicants must be able to demonstrate drive, passion and a strong sense of team working, along with a desire to progress within our organisation. Successful candidates will also have great communication, both verbal and written.

The Clinical Trial Subject Matter Expert (CT SME) provides clinical expertise and advice regarding study protocols to a multi-disciplinary production team to enable the creation of various training modules for our clients. The CT SME reviews the training modules for 100% accuracy to the protocol and to ensure that it provides value to the end user.

Job responsibilities include:

• Accountable for determining the protocol-specific challenges for each protocol that has been assigned to the team and identify possible Firecrest solutions.
• Responsible for reporting to the Production Team at project start up to provide protocol information and background to aid in the teams understanding of the study.
• Required to provide support to the team PM at Client External Kick Off meetings.
• Responsible for supporting the team Technical Writer (TW) to produce Firecrest scripts that are 100% technically accurate for our site training modules.
• Responsible for the technical review of scripts prepared by other members of the team to ensure 100% technical accuracy to the protocol and relevance to the end user (i.e. Investigators and Site Staff).
• Takes ownership for the technical accuracy of all product graphics ensuring that they are both informative and 100% correct.
• Oversees the review of all modules prior to final release to the client to ensure that all quality standards have been met.
• Responsible for providing clinical guidance when required to the sales team.
• Assumes collective responsibility for successful on-time completion of projects.
• Responsible for ensuring that high quality standards and work practices are maintained across teams.
• Works to constantly enhance the product, encouraging teams to apply new ideas (interactions, graphics,
• Act as mentor and help train junior staff when required.

The ideal candidate will have the following skills, knowledge and/or experience:

• A minimum of two years’ experience in the clinical trials industry, preferably as a CRA.
• Familiarity in working with clinical trial protocols, ideally across several therapeutic indications.
• Excellent communication skills
• Potential background as either a Study start up coordinator/Clinical Trial Study Coordinators or Clinical Trial Research Nurse would be considered
• Minimum of Bachelors degree or local equivalent.

Benefits of Working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development.  We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career.  We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. 

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

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.   

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