合同经理，研发，法务/高级现场合同负责人
Contracts Manager, Research and Development, Legal / Senior Site Contracts Leade
当我们的价值观一致时，我们能够实现无限可能。
在Parexel，我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入，我们提供的每项临床开发解决方案都源于一种特别的东西——对所做工作的深刻信念。
无论我们在Parexel做什么，都在为最终惠及患者的疗法开发做出贡献。我们认真对待工作，以同理心去做，并致力于带来改变。
外部职位描述
职位概述：
研发法律合同经理将负责提供合同管理支持，以协助临床试验。
主要职责：
合同谈判与审核
- 审核并谈判保密披露协议（CDAs）、临床试验协议（CTAs）和知情同意书（ICFs），直接处理或由合同研究组织（CROs）上报处理
- 及时识别并上报合同条款给相应的合同负责人、律师和其他相关利益相关方
- 与CRO合同人员（包括医疗机构的合同人员）建立牢固的工作关系，以加快合同执行和冲突解决，确保临床试验高效进行
- 跟踪并推动合同执行，包括识别剩余的合同问题，确定适当的决策者并召集会议以推动高效的决策
- 向相关利益相关方有效传达优先级和紧急程度
- 参与跨职能团队，确保合同执行和策略达到目标
合同管理/运营管理
- 成为客户合同管理系统（CMS）及流程方面的专家
- 与法律运营和CMS团队紧密合作，确保合同在系统中得到妥善管理，并开发改进和更新
- 与法律及其他同事合作，解决日常合同问题，主动排查并实施短期和长期的合同改进和效率提升
- 按需支持和管理合同模板和指南；跟踪协议中的协商条款，识别合同指南的潜在更新
- 根据需要提出更新的合同指南
查看英文原文
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
External Job Description
Job Summary:
The Contracts Manager, Research and Development Legal will be responsible for providing contract management to support clinical trials.
Key Accountabilities:
Contract Negotiations and Reviews
- Review and negotiate Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and Informed Consent Forms (ICFs), either directly or as escalated by Contract Research Organizations (CROs)
- Identify and escalate contract terms to appropriate contract owners, attorneys, and other appropriate stakeholders, in a timely manner
- Build strong working relationships with CRO contracting staff (including contracting staff at medical institutions) to facilitate quick contract executions and conflict resolutions ensuring efficient conduct of clinical trials Track and drive contracts to execution, including identifying remaining contracting issues, identifying appropriate stakeholders to reach decisions and convening meetings to drive efficient decision-making
- Identify and effectively communicate priorities and urgencies to applicable stakeholders
- Participate in cross-functional teams to ensure contract executions and strategies are achieving targeted goal
Contract Administration / Operational Management
- Serve as an expert in client Contract Management System (CMS) and processes
- Work closely with Legal Operations and the CMS teams to ensure contracts are properly managed in the system and develop enhancements, improvements and updates
- Partner with Legal and other colleagues to address and solve day-to-day contracting issues and proactively troubleshoot and implement short-term and long-term contract improvements and efficiencies
- Support and manage contract templates and guidelines, as requested; track negotiated terms across agreements and identify potential updates to contracting guidelines
- Propose updated contracting guidelines, as needed
Compliance with Parexel Standards
- Complies with required training curriculum
- Completes timesheets accurately and timely as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
- General understanding of applicable laws and regulations as well as legal risks that might impact research and development of a commercial-stage biotech company (including confidentiality, intellectual property, anti-kickback/anti-bribery laws, FDA regulations, and privacy laws)
- Strong written, oral communication, interpersonal, and organizational skills
- Ability to work independently as well as in a team environment
- Ability to effectively prioritize workload and communicate priorities
- Ability to work and adapt in a complex and dynamic organization handling multi-faceted projects with tight timelines
- Ability to interact effectively and productively with all levels within an organization in a calm and professional manner
- Motivated to work in a fast-paced environment
- Detail oriented
Knowledge and Experience:
- Minimum 5 years of site contracting experience in a CRO or pharma setting
- Experience negotiating CDAs, CTAs, and ICFs, either in a pharmaceutical/biotech company or CRO
- Experience negotiating with a Contract Management System (CMS) required
- ICF review experience is preferred
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Originally posted on Himalayas