You will need to login before you can apply for a job.Study Start Up Associate I (Medical Affairs)Sector: Health and Medical, LegalRole: AssociateContract Type: PermanentHours: Full TimeAs 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:Perform investigator recruitment activities utilizing phone scripts, questionnaires, study site materials, and other tools for evaluating investigative sites.Utilize the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked.Perform 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.Support investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.Perform study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate, and complete.Document site and Sponsor contact and study interactions in a timely and professional manner.Assist with the resolution of investigational site/data queries.Provide quality review of the informed consent template.Follow up with sites for trial invoices and ensure 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 submissions (CEP and CONEP).Having clinical trials support or pharmaceutical industry experience.Fluent 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 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, which helps us better serve our people, patients, customers, and communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization.
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