Responsiblities ??? Facilitate to identify and select trial vendors, including but not limited to CROs, Labs, SMOs for clinical studies together with other stakeholders. Negotiate the quotation and contract. ???Require, manage and coordinate the study resource internally and externally. ???Set-up and/or lead the study team (internal & external) to set up and review study plans including timeline, trial supplies, essential documents and all other plans (project management plan, monitoring plan, training plan, and etc.) properly. ???Oversee and manage the clinical operational activities with CROs, third-party vendors, consultants and internal personnel to execute clinical studies to ensure that the studies proceed according to the plans ???Oversee study start-up, conduct and close-out activities, including site feasibility ???Oversee clinical site monitoring activities and review/approve monitoring visit reports. ???Oversee the trial quality by conducting co-monitoring visits, lead risk & issue identification and resolution, and other related quality activities ???Manage CRO, third-party vendors and consultant’s work, including review and approval of scope of work, contract, budget and invoices ???Develop collaborative relationships with internal partners, external organizations, key opinion leaders, and investigators ???Collaborate with CRO study directors and project managers to foresee and solve problems ???Consult and coordinate with the internal medical team, drug supply team and external consultants regarding the design and conduct of studies Qualifications ???Bachelor’s degree or master’s degree in a medicine-related discipline. ???At least 5 years of working experience including 1.5-3 years of clinical operations project management experience. ???Experience with clinical studies in Australia or US is a plus. ???Knowledge of the relevant drug development process including project and site management, local and international regulations, ICH-GCP, drug safety requirements, data management processes, budget and vendor management and other functions or industry knowledges. ???Ability to travel extensively within country and rarely for Intercontinental trave as well. ???Excellent communication skills. ???Fluent written and spoken English, and proficiency in Chinese is a plus (for abroad candidates only). ???Ability to handle high volume of work and tight deadlines. ???Proficiency in MS Office, including Word, Excel, and PowerPoint.