Clinical Development Liaison
盈帆达医药咨询(上海)有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2016-10-17
- 工作地点:上海
- 招聘人数:若干人
- 工作经验:3-4年经验
- 职位月薪:15000-19999/月
- 职位类别:临床研究员
职位描述
职位描述:
Responsibilities:
Business Development
Identify, screen, evaluate and develop investigators for clinical trial participation
Develop and maintain relationships with major institutions
Develop new sites
Provide input to study manager on protocol and enrollment feasibility for studies
Partner with study manager on the design and contribute to the strategy of clinical study protocols
Attend key therapeutic meetings, departmental education/business updates and other forms of technical and non-technical training
Maintain technical expertise within a therapeutic area to engage in scientific discussions with the investigator and institution personnel
Support Country Study Manager (CSM) on Final Patient Allocation (FPA) process
Negotiate budgets and contracts with institutions and investigators with an emphasis on usage of standard agreements and Fair Market Value (FMV)
Business Management
Primary interface with investigators
Manage the link between site and the Third Party Organization (TPO)
Single point of contact for institutions to identify and resolve business process barriers
Drive key/critical site level patient allocation
Responsible for site specific enrollement and first patient visit
Interact and influence the development and implementation of site initiation/enrollment risk plans for clinical trials
Collaborate with Lilly partners, Quality, and other study team members to resolve/escalate site specific issues when necessary
Effectively understand and use resources to resolve investigator needs
Apply broad clinical research knowledge to impact strategy and process
Understanding of drivers that run the business and how other areas of the business are affected
Leverage strategic knowledge of institution’s decision making process and deliver mutually acceptable business solutions
If applicable, involvement/oversight of fully outsourced trials
External Influence
Develop and maintain relationships with major therapeutic institutions
Maintain active relationships and/or memberships with applicable research and disease-state organizations
Influence and challenge internal and external environmental factors that impact clinical research strategy
Communication/Information Management
Serve as primary point of contact for site personnel relative to business related issues
Actively listen and respond to customer needs
Serve as an effective communication “bridge” between our customer/partners and Lilly
Coordinate, communicate, develop best practices, and build relationships using cross-functional teamwork
Compliance
Responsible for understanding and complying with all regulatory requirements
Responsibilities include understanding and following all compliance, procurement, legal, financial and Global Medical Standards and Procedures
Maintain familiarity with regulations and guidelines regarding patient enrollment practices
Responsible for the initiation and evaluation of Anit-Corruption Due Diligence (ACDD) with inverstigators
Provide audit and inspection support
基本资格要求
Other Information/Additional Preferences:
Bachelor’s degree or equivalent work experience in a scientific or health-related field
Preferably at least 2 years previous work experience in Clinical Trial/Development experience and good working knowledge of Clinical Research Process
Computer skills (e.g. Excel, Word, PowerPoint).
Fluent in English
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Responsibilities:
Business Development
Identify, screen, evaluate and develop investigators for clinical trial participation
Develop and maintain relationships with major institutions
Develop new sites
Provide input to study manager on protocol and enrollment feasibility for studies
Partner with study manager on the design and contribute to the strategy of clinical study protocols
Attend key therapeutic meetings, departmental education/business updates and other forms of technical and non-technical training
Maintain technical expertise within a therapeutic area to engage in scientific discussions with the investigator and institution personnel
Support Country Study Manager (CSM) on Final Patient Allocation (FPA) process
Negotiate budgets and contracts with institutions and investigators with an emphasis on usage of standard agreements and Fair Market Value (FMV)
Business Management
Primary interface with investigators
Manage the link between site and the Third Party Organization (TPO)
Single point of contact for institutions to identify and resolve business process barriers
Drive key/critical site level patient allocation
Responsible for site specific enrollement and first patient visit
Interact and influence the development and implementation of site initiation/enrollment risk plans for clinical trials
Collaborate with Lilly partners, Quality, and other study team members to resolve/escalate site specific issues when necessary
Effectively understand and use resources to resolve investigator needs
Apply broad clinical research knowledge to impact strategy and process
Understanding of drivers that run the business and how other areas of the business are affected
Leverage strategic knowledge of institution’s decision making process and deliver mutually acceptable business solutions
If applicable, involvement/oversight of fully outsourced trials
External Influence
Develop and maintain relationships with major therapeutic institutions
Maintain active relationships and/or memberships with applicable research and disease-state organizations
Influence and challenge internal and external environmental factors that impact clinical research strategy
Communication/Information Management
Serve as primary point of contact for site personnel relative to business related issues
Actively listen and respond to customer needs
Serve as an effective communication “bridge” between our customer/partners and Lilly
Coordinate, communicate, develop best practices, and build relationships using cross-functional teamwork
Compliance
Responsible for understanding and complying with all regulatory requirements
Responsibilities include understanding and following all compliance, procurement, legal, financial and Global Medical Standards and Procedures
Maintain familiarity with regulations and guidelines regarding patient enrollment practices
Responsible for the initiation and evaluation of Anit-Corruption Due Diligence (ACDD) with inverstigators
Provide audit and inspection support
基本资格要求
Other Information/Additional Preferences:
Bachelor’s degree or equivalent work experience in a scientific or health-related field
Preferably at least 2 years previous work experience in Clinical Trial/Development experience and good working knowledge of Clinical Research Process
Computer skills (e.g. Excel, Word, PowerPoint).
Fluent in English
职能类别: 临床研究员
公司介绍
Why Syneos HealthTM? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.
联系方式
- Email:claire.liu@inventivhealth.com
- 公司地址:地址:span国贸银泰C座