FSPxGlobal Pharma
*5年以上SSU/CRA/临床合同草拟相关经验
*英语听说读写流利

Summary:

Oversees administration and negotiation processes for complex site contracts that support projects within Clinical Operations on a global scale. Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as technical expert across all Site Contracts functions. Trains and mentors site contracts staff and proactively identifies ways to improve internal project operations. Establishes strong working relationships with customer and internal project teams. May lead internal team education or process improvement initiatives.


Essential Functions:

1. Negotiates and prepares contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.

2. Anticipates risk/benefit issues, assists with remedial action plans, and troubleshoots to resolve any concerns.

3. Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.

4. Assists Contract Managers or other site contracts staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.

5. Generates amended documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.

6. Creates and maintains document status reports and updates department team members on a regular basis and ensures appropriate documentation is maintained for all exceptions.

7. Collaborates with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues.

8. Facilitates the execution of contracts by company signatories.

9. Supports the maintenance of contract templates and site specific files and databases.

10. Serves as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Other Responsibilities:

Performs other work-related duties as assigned, including support to other start-up functions as required at a country level. Minimal travel may be required (up to 25%).


Requirements:

BA/BS degree in related field or equivalent combination of education and experience. Clinical research, contracts, or related experience that includes working in a team-oriented environment preferred. Strong skills in Microsoft Office Suite, email, and voicemail. Strong organizational, presentation, documentation, and interpersonal skills. Ability to handle multiple tasks to meet deadlines in a dynamic environment.


Syneos Health赛纽仕医药是一家全面整合生物制药解决方案的公司，旨在帮助客户加快推出新疗法的速度。我们站在产品研发的角度，战略性地融合临床研发、医学事务和商业能力，以及时应对最新市场变化。 想了解更多关于我们如何缩短从实验室到现实生活的距离，请访问官网或订阅我们的播客。

其他信息
语言要求：英语
行业要求：全部行业
所属部门：Clinical