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.