Senior Study Support Assistant
hace 3 días

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.

As a Study Support Assistant (SSA) , you will play a key role in independently assisting the team to ensure the most effective and efficient study start up, by providing administrative and tracking support.

As part of your journey with us, we also believe in supporting you in your career progression by providing you tailored training and mentoring programs to help you succeed!

The Role

The SSA will support the Site Activation Lead in the management of Trial Master File (TMF) activities on large studies.

Complete tasks including; tracking, filling, collating and verifying, for completeness, submission documentation for submission to the Regulatory / Competent Authority (CA) / Ethics Committee(EC) and other relevant authorities and helping with the translation of these documents

Look after the submission progress tracking by updating the relevant ICON / Sponsor tracking system.

Be proficient with ICON / Sponsor Clinical Trial Management System (CTMS).

Setting, up, coordinate and maintain department electronic filing systems.

Coordinate and attend meetings as requested and assist in the production of slides, overheads etc. as needed

Assisting in the co-ordination of payments to CA / EC and other relevant authorities and be familiar with ICH GCP and ICON SOPs

To be successful in the role you'll need :

Bachelors of Science, Medicine, Biotechnology or relevant clinical areas

Experience of working in a clinical environment for a CRO, pharmaceutical or hospital setting as a SSA, CTA or similar

Experience of Study Start Up is highly desirable

Familiarity with ICH GCP advantageous

You will possess excellent written and verbal communication in English

This position can be based in most European locations

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 through the form below.

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