Syneos FSP Site Contracts Specialist的主要职责(Syneos FSP Site Contracts Specialist的工作经验要求有哪些)

Syneos FSP- Site Contracts Specialist的主要职责(Syneos ...
Syneos FSP- Site Contracts Specialist在临床试验领域中负责合同相关的专业工作。主要职责包括准备和审查合同文件、谈判合同条款、管理合同执行和合规性、协调内部和外部资源，以及解决合同相关的任何问题。此外，他们还需要与研究团队、供应商和监管机构保持沟通，确保临床试验的顺利进行。这一职位要求具备良好的法律知识、沟通协调能力和项目管理能力。

Syneos FSP- Site Contracts Specialist的主要职责(Syneos FSP- Site Contracts Specialist的工作经验要求有哪些)

学历要求：本科
工作经验：2年及以上
公司性质：外资（欧美）
公司规模：10000人以上  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，请访问或订阅我们的播客。 JOB SUMMARY Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with moderate oversight from the SSU Country Manager. 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 junior team members and proactively identify ways to improve internal project operations. Establishes strong working relationships with customer, internal project teams and sites. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.May participate in internal team education or process improvement initiatives. JOB RESPONSIBILITIES -Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. -May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. -Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site. -Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues. -Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. -Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented. -Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings. -Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues. -Supports in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions. -Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time. -Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues. -Facilitates the execution of contracts by company signatories. -Maintains contract templates and site specific files and databases. -Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products. Maintains and updates training material for site contract team. -Acts as a 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. -Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. -Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. QUALIFICATION & REQUIREMENTS -BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred. -High level of contracts management experience. -Experience in a contract research organization or pharmaceutical industry essential. -Strong knowledge of the clinical development process and legal and contracting parameters. -Strong computer skills in Microsoft Office Suite. -Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations. -Excellent understanding of clinical trial process across Phases II-IV and ICH GCP. -Good understanding clinical protocols and associated study specifications. -Excellent understanding of clinical trial start-up processes. -Project management experience in a fast-paced environment. -Good vendor management skills. -Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation. -Strong organizational skills with proven ability to handle multiple projects excellent communication. -Quality-driven in all managed activities. Strong negotiating skills. Strong problem-solving skills. -Ability to mentor, lead and motivate more junior staff. -Demonstrate an ability to provide quality feedback and guidance to peers Contribute to a training and Quality assurance plan within SSU and update SOPs/WI.