高级合同与预算专员
Senior Contracts and Budget Associate
职位概述：
审核、起草、谈判并跟踪各种法律协议，包括保密披露协议（CDA）、初步临床试验协议（CTA）、临床试验协议修订（CTA-A）、站点预算和其他各类文件。将与临床运营研究团队紧密合作，并发挥行政角色，确保交付成果符合定义的项目时间表和期望。
工作的主要职责包括但不限于：
• 起草和谈判协议/修订，如保密披露协议（CDA）、临床试验协议（CTA）和修订（CTA-A）、供应商合同和站点预算。
• 根据需要与北美和欧洲内部研究团队进行互动
• 与站点就各类协议进行互动
• 与发起方就指定协议进行互动
• 与主管及各种内部/外部利益相关者合作解决合同问题
• 确保遵守公司政策、流程和合同标准
• 向相关研究团队成员和发起方通报合同谈判和执行的进展情况
• 协调协议的执行
• 支持合同文件和数据库的维护，包括电子邮件和文档归档
• 其他指派的任务
资格要求：
最低要求：
• 本科学位，或在临床研究或其他类似行业环境中具有同等合同管理经验
其他要求：
• 3年相关经验，起草、审核和谈判与临床研究相关的协议，例如保密协议、临床试验协议等，以及管理、控制和跟踪合同流程的经验
• 具有合同研究、生命科学、生物科技或制药行业经验者优先
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Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents. Will work closely with the Clinical Operations study team and play an administrative role to ensure deliverables are in alignment with defined project timelines and expectations.
Essential functions of the job include but are not limited to:
⢠Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), vendor contracts and site budgets.
⢠Lead interactions with the North American and European internal study teams, as applicable
⢠Lead interactions regarding the various agreements with the Site(s)
⢠Lead interactions regarding assigned agreements with the Sponsor(s)
⢠Work with supervisor and various internal/external stakeholders to resolve contractual issues.
⢠Ensure adhered to company policies, procedures, and contracting standards.
⢠Update relevant study team members and sponsors regarding the status of contract negotiations and execution.
⢠Coordinate execution of the agreements
⢠Support the maintenance of contract files and databases, including email and document archiving.
⢠Other duties as assigned.
Qualifications:
Minimum Required:
⢠Bachelorâs degree, or equivalent contract management experience preferably in a clinical research or similar industry setting
Other Required:
⢠3 years of relevant experience drafting, reviewing and negotiating agreements related to clinical
research i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management,
⢠control and tracking of the contract process.
⢠Experience in contract research, life science, biotech or pharmaceutical industry is preferred.
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