• The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. • Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally. • The role involves leading the cross functional project team to meet or exceed deliverables. • Manages the day-to-day execution of assigned trials to ensure completion of established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. • Supports the Clinical Trial Lead in the development of specific study plans, development of core study documents, and systems set-up to ensure operational excellence in execution of the clinical trial protocol. • Develops required study specific training materials, including supporting the coordination of Investigator meetings. • Leads and chairs meetings with QSDO team members, including representatives from CTDU, CTAU and CSO to ensure the successful delivery of site activation and recruitment targets and evaluation recruitment strategies. • Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progress, issues, and risks to key SMT stakeholders during regularly scheduled meetings. • Depending on study needs, manage third-party study vendors including study specification creation, collection, and finalization in conjunction with the relevant functional SMEs. • Proactively identifies and resolves issues that arise during trial conduct, managing the escalation of trial-related issues. • Participates in and/or facilitates cross-functional collaboration and problem solving to ensure risk mitigation. • Supports the team to ensure timely data cleaning, data analysis and the availability of top line results. • Ensure project deliverables meet quality standards. • Ensures compliance with relevant sponsor policies and procedures. • Works with the Study Vendor Specialist to define project study specs during vendor setup. • Facilitate effective communication and collaboration among team members. • Adheres to project budgets, ensure timely billing and invoicing.