.As a Study Start Up Associate II 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.**Qualifications**:- Knowledge of local regulatory authority drug research and development regulations required.- Clinical trials support or pharmaceutical industry experience required- Experience with US sites- Advanced English**Why ICON?**At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.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
