Job Title

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: Collect, review, and track relevant study documents.Support set-up, maintenance, closeout, and archiving of the Trial Master File (TMF). Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.Support production of study documents, ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system.Set-up, populate, and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems.Manage and contribute to the coordination and tracking of study materials and equipment.Assist in the tracking and reconciliation of invoices.Support study team and provide study metrics/reports during the study, audits, and regulatory inspections.Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g., study team meetings, monitor meetings, investigator meetings, and advisory boards.Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents.Prepare and distribute study-related correspondence. Contribute to and distribute material for meetings, newsletters, and websites.Your qualificationsEssential Skills/Experience:University degree/bachelors degree, or equivalent experienceGood understanding of drug developmentMinimum of 1-2 years experience of administrative/operational support of clinical studiesDesirable Skills/Experience:Knowledge of ICH-GCP principlesTeam-orientedAbility to coordinate and prioritize multiple tasks and deliverablesProactive approachHigh degree of flexibilityDemonstrated verbal and written communication skillsCompensation will be determined based on factors such as geographic location, work experience, education/training, and skill level