Study Start Up Associate II

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

With our patients at the center 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 Study Start Up Associate II, you will:

• Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.

• Embrace and contribute to ICON’s culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.

The Role:
• Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
• Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
• For specific projects, serve as the main point of contact with Sponsor, Project Manager, Clinical Trial Manager, Site Activation Lead, other functional leads and third parties. Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes.
• Assume responsibility as Subject Matter Expert (SME) as required.
• Coordination of all necessary translations required for any start-up documentation.
• Attend study team meetings as required.
• Other duties as assigned

What you need:

• A Bachelor’s Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.

• A minimum of 3 years of experience or understanding of clinical study start up and regulatory requirements and activities. (SSUA II)

• Fluency in the local language and English is essential.

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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