上海招聘

Job Summary

 

The position provides customer focused leadership in managing and delivering the operational aspects of one or more clinical projects at various clinical phases, from imaging charter development and study startup to final deliverables. May oversee less experienced Project Managers (PMs) and Project Coordinators (PCs) and have line management responsibilities.

 

Job Responsibilities

 

• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
• Leads clinical team to ensure quality, timelines and budget management.
• Accountable for all project deliverables for assigned projects and/or project regions.
• Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.

 

Reporting And Communication

 

• Accountable for maintenance of project information on a variety of databases and systems.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
• Independently prepares, coordinates, and presents project material at internal and external meetings.
• Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication.
• Prepares project management reports for clients and management.
• Implements resource strategies to achieve project goals.
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.

 

Management

 

• May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
• May be required to line manage other project management team members and clinical monitoring staff

 

Qualification Requirements

 

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
• Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.
• Strong ability to manage time and work independently.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
• Fluent in spoken and written English

 

EyeKor Inc.

 

EyeKor is an imaging CRO in providing ophthalmic clinical trial imaging data management service and specializes in masked, independent reading center services for various ophthalmic imaging modalities and testing methods. EyeKor provides is a cloud-based software application, EXCELSIOR?, which was built specifically for supporting image data collection and management for ophthalmic clinical trials. EXCELSIOR? utilizes the latest web and imaging technologies for data standardization, analysis, grading and reporting. In the last 5 years, EyeKor has participated in 110+ clinical trials in ophthalmology, with 40+ are large, global, multi-center, phase III projects.

海盐威康医疗技术有限公司是一家由美国Eyekor Inc独资成立的子公司，Eyekor Inc是一家位于美国专注于眼科，利用领先的医学数据和影像处理软件技术，服务全球的药企医械和CRO，为其临床研发提供流程管理和数据、影像处理的服务型公司。公司成立日期为2012年2月15日，是首家通过美国FDA认证的眼科临床研究平台。
海盐威康医疗技术有限公司在国内将专注于高端医疗设备和生物制药的研发、技术转让及技术服务；临床试验/影像数据的管理与统计分析工作。