职责描述：Performs the role of Local Clinical Project Manager (LCPM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in Genor Bio Medical Department procedural documents. May perform the role of Global Clinical Project Manager (GCPM) for single country as described in Genor Bio Medical Department procedural documents. LCPM is a person within Trial Co-ordination and CRA responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries.The LCPM is the primary point of contact at a country level for assigned studies.The LCPM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. LCPM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants, CRA and LCPMs. The LCPM may have some site management responsibilities. 任职要求： 1 Prepares country specific informed consent in accordance with Genor Medical Department procedural document/templates. Reviews and manages site specific informed consent forms in accordance with Genor Medical Department SOPs, WIs and applicable regulations. 1 Obtains and maintains relevant local insurances 1 Acts as a local expert for regulatory affairs to ensure that the trial is in compliance with local regulatory requirements. 1 May also take Ｏn responsibility of CRA if required. 1 Organizes and ensures IEC/HA approvals and any import/export permits, if applicable. 1 Reviews and ensures completeness and accuracy of List of investigators for CSR. EDUCATION AND EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable. A minimum of a Bachelor of Science degree is required. A degree in a health or science related field is preferred.  Minimum 5 to 7 years of pharmaceutical and/or CRO clinical trial experience is preferred, with a minimum of 3 years as CRA role to manage sites in Australia.  Specific therapeutic area experience may be required depending Ｏn the position.  Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements.  Solid communication and computer skills required.  Good written and oral communication skills.  User knowledge in MS Office 365, Veeva Vault QMS or similar software  Excellent oral and written communication skills in English and ideally Ｏne other language (preferred Chinese)