Study Start Up Associate II - (Anvisa)

As a Study Start Up Associate you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.

You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks including writing ADaM specifications, programing ADaM datasets, programming efficacy outputs, and submission work.

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally

What you will be doing:

• Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
• Utilizes the Clinical Trial Management System (the CTMS) to ensure investigator recruitment activities are accurately tracked.
• Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
• Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
• Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
• Documents site and Sponsor contact and study interactions in a timely and professional manner.
• Assists with resolution of investigational site/data queries.
• Provides quality review of the informed consent template.
• Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments

You are:

• Knowledge of local regulatory authority drug research and development regulations required.

• Experience with ANVISA DDCM submissions
• Clinical trials support or pharmaceutical industry experience required

• Advanced English

What ICON can offer you:

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.