Project Manager, Australia

Join to apply for the Project Manager, Australia (Mandarin speaking) role at Emerald Clinical . At Emerald Clinical Trials , we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post‑marketing. Our therapeutic expertise spans renal, cardiometabolic, and oncology, where we make a significant impact on improving global health. About the Role The Project Manager is responsible for the development, conduct, and completion of research projects in accordance with the reasonable requirements of the originator. The role includes all aspects of study management activities, including cross‑functional team leadership and coordination, client communication and management, financial management, and overall study delivery. The Project Manager ensures studies are resourced effectively, managed efficiently, and completed to the highest standards of Good Clinical Practice (GCP), regulatory requirements, and applicable Standard Operating Procedures (SOP). The Project Manager mentors and coaches junior staff and works independently or with support from portfolio delivery leads or line managers. Your Responsibilities Project Kick‑off Attend relevant project‐specific meetings, including formal kick‑off meetings. Develop the project plan and other internal project management documents. Assist the originator in the development of project‐specific documents such as protocol and participant information forms as requested. Coordinate the feasibility planning and selection process of project sites. Identify project‐specific activities that need to be outsourced and be involved in the selection of suitable vendors. Project Implementation and Closure Contribute to the preparation of the project‐specific budget where applicable. Track budget for the allocated portion of the project and provide relevant portions of the budget by guiding team and vendors on scope, forecasting, and invoicing as agreed with the customer. Track project scope and propose scope changes for assessment. Identify potential clinical sites, oversee or conduct feasibility through questionnaire, interview, and/or site visit as applicable. Oversee the set‑up of sites within the relevant region in accordance with SOPs, protocol, and all applicable regulatory guidelines. Contribute to the calculation of project staffing levels and the identification of appropriate materials for the project. Monitor project progress against timelines, deliver project milestones as agreed with the customer, and coordinate project administration such as study management committee meetings and newsletters. Liaise with centre staff to ensure effective local management and act as a back‑up contact for site staff on all project‑related matters. Coordinate and drive internal project team to meet project‑specific deadlines. Assist with the development of project documentation such as site manuals and operating procedures. Review and sign‑off monitoring visit reports, ensure patient safety and adverse events are reported in accordance with regulatory requirements, and initiate filing conventions for the project. File and archive clinical project data at the end of the project and provide or contribute to progress reports for the project originator and other stakeholders. Maintain regular contact with the project team, including academic leads, and maintain contact with national coordinators working within the allocated region. Study Start‑up Co‑ordinate the feasibility planning and selection process of all centres. Manage the establishment of study centres by ensuring each centre has the necessary trial materials, contracts, agreements, and site research coordinators are fully equipped. Train site staff on data management tools and principles. Ensure timely preparation and submission to ethics and regulatory authorities, develop trial management systems, and assist with the development of monitoring plans. Manage the planning and set‑up of investigator meetings; prepare presentation material and present information at these meetings. Study Close‑out Work with the clinical team to ensure timely and successful completion of the trial. Coordinate close‑out visits and ensure final reconciliation of clinical supplies. Coordinate final archiving of study‑related documents. Data Management Ensure accurate and timely collection of data and maintain data quality, completeness, and resolution of queries. Manage the study to ensure adherence to protocol, SOPs, regulations, and ICH‑GCP. Ensure distribution and collection of essential documents, reports, and study materials. Financial and Contractual Analyze monthly financial reports, identify trends, and raise concerns as required. Understand all aspects of project finance responsibilities and follow appropriate escalation pathways. Maintain project utilization, revenue forecast, and gross margin across allocated projects to meet organizational goals. Review forecasts for allocated projects and develop contingency plans to address any slippage. Manage pass‑through report management and ensure billing is finalized within agreed timelines. Maintain a list of all scope‑change documentation and collaborate with the proposal team to update pricing tools and budgets. Seek opportunities for scope expansion and follow up with business development and sponsors. Customer Focus and Business Development Initiate and maintain high‑level relationships with internal and external stakeholders, including trial sponsor staff, key opinion leaders, hospitals, professional societies, and associations. Review and contribute to all scope‑change proposals for allocated projects before finalisation and sponsor review. Participate in bid‑defence presentations in partnership with business development, and lead the presentation for smaller, less‑complex regional studies. Quality Management Ensure allocated projects are conducted in accordance with the Emerald Clinical Quality Management Strategy. Work with key project team members to ensure audit and inspection readiness and complete follow‑up for all team members. Ensure compliance with file review plans and documentation as specified by the sponsor and/or Emerald Clinical. Co‑monitor activities in accordance with sponsor and/or Emerald Clinical requirements. Perform own quality control of all relevant processes and activities performed by the system. About You Fluent in spoken and written Mandarin. Experience managing early‑phase clinical projects is required. Bachelor’s or master’s degree in a science or related field. Previous experience on clinical projects within an academic, CRO, or pharmaceutical company environment. Approximately seven years of industry experience; prior CRA or site‑management role preferred. Experience managing projects across multiple regions and therapeutic indications, from early‑phase to late‑phase studies. Excellent working knowledge of ICH‑GCP and all applicable regulations and guidelines in the relevant regions. Client‑facing interaction or client management experience. Project finance management experience, CRO preferred. Strong interpersonal, presentation, and team‑leadership skills, including leading virtual teams in a cross‑cultural environment. Strong communication skills (written and verbal) and ability to present effectively. Flexibility and adaptability in the face of changing organisational priorities and ambiguous environments. Why Join Us? Purpose‑Driven Work : Contribute to clinical trials that genuinely improve lives, focusing on therapies in renal, cardiometabolic, and oncology. Global Reach, Local Expertise : Connect with local communities to build trust and meaningful engagement for every trial. Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer Competitive Compensation : A tailored salary and benefits package reflecting your skills and experience. Flexibility : Hybrid or remote working arrangements, depending on your location and role. Career Growth : Access to learning opportunities and a global network of scientific leaders to help you grow and develop. Employee Wellbeing : Programs and initiatives to promote work‑life balance, health, and team connection, including engagement surveys, recognition programs, and team‑building events. Global Opportunities : Exposure to diverse projects and clients across international reach. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal‑opportunity employer and encourage applications from all qualified candidates. Seniority Level Not Applicable Employment Type Other Job Function Project Management and Information Technology #J-18808-Ljbffr