As a Study Start Up Associate I 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 a dedicated resource to one of our clients, 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, programming ADaM datasets, programming efficacy outputs, and submission work.You will be partnering with one of the world's 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 evaluating investigative sites.Utilizes the Clinical Trial Management System (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 met and comply with applicable local regulatory requirements and ICH/GCP guidelines.Supports investigators and investigative staff in fulfilling obligations regarding 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:Knowledgeable of local regulatory authority drug research and development regulations.Experienced with ethical submission (CEP and CONEP).Have clinical trials support or pharmaceutical industry experience.Proficient in 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 designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, helping 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 organization.Interested in the role, but unsure if you meet all of the requirements? We 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.
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