Global Studies Associate

The Global Study Associate (CTA level) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Global Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

Your responsibilities include:

• Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work.
• Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.
• Collaborate with Site Management & Monitoring, extended study team and external vendors in collection of regulatory and other essential documents.
• Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection
• Contribute to electronic applications/submissions by creating and managing clinical- regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory Proactively plan and collate the administrative appendices for the CSR.
• Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements.
• Set-up, populate and accurately maintain information in tracking and communication tools and support team members in the usage of these tools.
• Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs.
• Support the GSD/GSAD with tracking, reconciliation and follow-up of the study budget/ payments in relevant systems 
• Contribute to application, coordination, supply and tracking of study materials and Contribute to collection of study supplies, if required, at the study close-out.
• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs
• Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors.

Your qualifications

• Education in in medical or biological sciences or discipline associated with clinical research preferred
• Proven organizational and analytical
• Previous administrative training/experience.
• Computer proficiency in day-to-day
• Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines.
• Excellent verbal and written communication in English.
• Demonstrate ability to work independently, as well as in a team environment.
• Willingness and ability to train others on study administration procedures.
• Global study support experience required 
• Veeva Vault experience preferred

Compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level

Benefits of Working in ICON:revious administrative experience preferably in the medical/ life science field

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.