• Plan and oversee multiple customer projects to ensure timely completion within budget and scope. • Designate project resources and monitor progress while keeping stakeholders updated. • Act as a liaison between Irth’s customers and internal teams to ensure smooth project completion and success. • Manage changes to the project scope, schedule, and costs using appropriate techniques. • Provide consistent project updates to stakeholders regarding strategy and progress. • Manage overall customer relationship and satisfaction during all phases of project execution.

• Provide administrative and technical support to Project Team including planning, organizing and coordinating responsibilities of project administration. • Maintain procedures, guidelines and documentation and ensure appropriate maintenance of project records and all regulatory documents. • Complete data entry and maintenance of database repositories. • Assist in preparation or creation of reports and complete data collection for analysis. • Completes review, coordination and compilation of files and other materials. • Distributes project documents and supplies. • Processes and tracks local regulatory, study specific or department documents. • Performs file review. • Organizes and maintains correspondence files and other departmental records. • Analyzes and reconciles project documents, metrics and findings reports within specified timelines. • Provides clarification and resolution of findings related to documentation. • May assist with translation materials and translation QC upon request. • Composes, copies and distributes communications, reports, documents and forms. • Maintains vendor trackers. • Provides accesses to company, client and vendor systems. • Processes local payments (translations, EC/IEC, other local vendors, etc.). • Assists on project management ad-hoc activities, producing reports or on study plan edition. • Coordinates team conference calls and completes and distributes meeting minutes from internal/client/vendor meetings as applicable. • Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance. • Maintains a basic knowledge of project protocol and the ability to implement project plans with specific guidelines and accountable for meeting applicable project timelines.

• Provide administrative and technical support to Project Team • Maintain procedures, guidelines and documentation • Complete data entry and maintenance of database repositories • Assist in preparation or creation of reports • Coordinate team conference calls and distribute meeting minutes • Serve as a resource to the project team

• Serve as the Project Lead and primary sponsor contact. • Accountable for overall delivery of the project (quality, time, cost). • Establish and communicate customer expectations to the project team. • Lead cross-functional project team to meet or exceed deliverables. • Ensure compliance with organization policies, SOPs, ICH-GCP. • Responsible for vendor management and financial stewardship at a trial level. • Drive Risk Identification and Issue Resolution at project level. • Manage out-of-scope activity and negotiate contracts.