• Streamline activities of project teams and ensure consistency of Clinical Operations processes across Asia Pacific region. • Ensure meeting study milestones by project teams on a country level. • Report study progress to clients and global stakeholders. • Act as project management contact for the project team and PSI support services. • Perform study status review and progress reporting, collect and report project status updates. • Develop and update project planning documents, essential study documents and project manuals/instructions. • Ensure that the project timelines and subject enrollment targets are met. • Coordinate maintenance of study-specific and corporate tracking systems. • Oversee site selection and startup, site contractual and budget negotiations. • Supervise project team and site training, perform field training of monitors tailored to the project needs. • Ensure team compliance with project-specific training matrix. • Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits. • Review site visit reports and ensures monitoring and reporting standards are met. • Oversee investigator and site payments. • Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings. • Might be involved in regional project oversight for APAC.

• Provides day-to-day oversight and coordination for a team of up to 8 Site Coordinators/ Site Administrators, ensuring alignment with project goals, operational standards, and quality expectations. • Conducts trainings to Site Coordinators/Administrators on clinical trial procedures, ensuring they have the necessary knowledge, skills, and tools to support study operations effectively. • Conducts regular quality checks on the work performed by Site Coordinators and Site Administrators to ensure tasks are completed in compliance with ICH GCP, relevant procedures, and applicable regulations. • Acts as the first line of operational support for Site Coordinators and Site Administrators, providing hands-on assistance and troubleshooting to resolve study-related issues promptly. • Supports management in identifying clinical research opportunities by sharing information on available trial pipelines and relevant research networks. • Collaborates with other team members during contract and budget negotiations; oversee Investigator, Site and MO1 payments utilizing MO1 tools to ensure timely contract execution and payment processing in alignment with agreed timelines. • Reviews and ensures timely and complete entry of study-specific information into the MO1 CTMS for the sites assigned to Site Coordinators, ensuring accuracy and compliance with study timelines and requirements. • Monitors Site Coordinators' support of patient recruitment activities to help achieve enrollment targets. • Promotes effective communication and collaboration between the site team, Milestone One team, and Medical Institution staff by safeguarding the timely flow of essential information and supporting a positive working environment. • Contributes to the preparation of the site team for audits and inspections by ensuring operational readiness and providing on-site support during these activities. • Fosters continuous improvement in site operations by proposing process enhancements and supporting the implementation of new operational tools and practices. • Act as the main line of communication between the Sponsor or CRO and the site. • Ensure response to feasibility questions are provided in due time. • Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center. • Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution. • Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals. • Maintain study specific and general tracking of documents at the site level. • Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site. • Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations. • Proper handling, accountability and reconciliation of investigational products and clinical supplies. • Collect, handle and maintain all site-specific regulatory documents as needed. • Facilitate and support the contract and budget negotiations at the site level. • Support Investigator and Site payments and processes as needed. • Schedule and/or perform study procedures as per study requirements and delegation of responsibilities. • Prepare for and participate in onsite study audits or regulatory agency inspections. • Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).

• Constantly maintain and generate relations with Investigative Sites • Maintain and refine the internal site database in cooperation with Study Startup, Clinical Operations and Process Improvement • Participate in development of improvement strategies for the site identification process • Create the initial list of potential sites • Communicates with project teams to define strategy and methodology of initial and follow-up site contacts • In cooperation with the project team maintain a study site identification tracker • Liaise with project teams to evaluate status and progress of site identification, to identify and highlight any potential risks or issues to timelines or objectives • Perform due diligence check of regulatory limitations applicable to the recommended investigators or clinical sites • Participate in project team meetings during study startup, as needed • Support the project team throughout study startup and further on

• Oversee, manage, and coordinate activities of project teams • Ensure consistency of Clinical Operations processes across regions • Meet study milestones on a country and regional level • Ensure compliance with industry regulations and essential study documents • Collect and report project status updates internally and externally • Develop and update project planning documents • Manage Key Performance Indicators (KPIs) for clinical project teams • Coordinate site contractual startup and budget negotiations • Establish communication lines within the project team • Conduct therapeutic area training of the project team