百济神州
(Associate) Contract Manager, Clinical Business Operations
岗位职责
of the Job: • Oversight of planning, drafting, negotiating, tracking, and execution of site/investigator contracts which may be subcontracted to an external service provider or managed internally • Ensures final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal and regulatory requirements. • Provide study-level oversight and guidance for clinical site contract negotiations, identify any potential risks, and be accountable for the overall contracting timelines/lifecycle in various regions. • Serve as the study-specific point of contact with the BeiGene Clinical Operations team and legal team on-site/investigator contract and budget matters. • Oversee a team of Site Contract Associates or equivalent at a Project level to ensure contracts in the region are completed per company standards/timelines. Implement mitigation plans as necessary in the assigned region. • Serve as an escalation point for unresponsive sites, site budget negotiations and ensure costs are approved within BeiGene FMV standards. • Adapts CBO’s plan and priorities to address resource and operational challenges • Training and mentoring of new members of the local Contracts Team regarding financial/contractual issues and sharing experiences. • Contribute to process improvements, knowledge transfer and best practice sharing. • Ensure all agreements are executed in a timely manner, contributing to efficient site start-up timelines. • Organizes and prioritizes multiple initiatives and sets clear plans for delivery • Effectively escalate/communicate to stakeholders and clinical teams in a professional and timely manner regarding contract issues that could impact project deliverables. • Responsible for management and administration of contracts and ensures compliance with corporate policies. • Serve as a backup to Site Contract Associates, as needed to handle out-of-office coverage. • Ensure proper delivery of fully executed clinical site contracts to CBO Payments teams and liaison with CBO payments team, as necessary. • Provide substantive guidance, monitoring, and support regarding clinical site contract deliverables, including undertaking activities identified in the CBO Roles/Responsibilities and/or Study Management Plan. • Review, apply, and maintain BeiGene Playbook to enhance the efficiency of negotiation in conjunction with BeiGene Legal. • Responsible for overseeing a Clinical Research Organization responsible for contract negotiations (if applicable). • Responsible for clinical contract management, study metric tracking and reporting. • Active participant in various study meetings. • Prepare program/study status reports. • Maintains a system for tracking progress and status of clinical budget/contracts. • Support activities of various contracts and subsequent contract amendments note to files and other contract-related requests. • Assist colleagues with the resolution of problems related to site budget, contract terms and conditions, compliance with BeiGene policy, and any other site contract-related issues. • Deliver training to CBO colleagues or other Business Units as needed. • Serve as a point of escalation for sites that are unresponsive or slow to negotiate. • Create and develop effective contract templates and tools • Performs other duties as assigned by management. • Works on Fair Market Value (FMV) analysis and processing of FMV exceptions (as needed). • Provides cost benchmarking for clinical budget activities using industry-based system analysis (as needed). Supervisory Responsibilities: • none Computer Skills: • Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Sharepoint etc. Other Qualifications: • Good knowledge of ICH-GCP, pharmaceutical related regulations and laws;
Good understanding of clinical trial contracting process, and relevant clinical operation practices;
Awareness and understanding of compliance and regulatory matters in clinical research • Proven negotiation, interpersonal and business skills • Strong planning and organizational skills and the ability to work independently and effectively in a dynamic environment with competing priorities • Sense of urgency and strong goal orientation; track-record of meeting deadlines and goals • Strong written and verbal communication including written and verbal fluency in English and local language (if not English) and interpersonal skills, including conflict resolution and problem solving. • Proactive and positive team player. Able to maintain high performance during times of ambiguity and change in the work environment. • Experience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable • Has knowledge of Intellectual Property issues, Publication issues, Indemnification issues and other standard issues of site contracts within the clinical research area. • Must be willing to work in a fast-paced environment with time-sensitive material. • Demonstrated ability to work effectively at all levels of an organization. Travel: Yes, 10% Education Required: Bachelor or higher degrees (life science preferred, including medicine, nursing, biology and laboratory technology) Computer Skills: Proficiency in use of MS office tools Other Qualifications: Fluent in written and verbal English; 5 years or above in clinical or drug development in the biotech/pharmaceutical/CRO industry or the relevant clinical research field; Good knowledge of ICH-GCP, pharmaceutical related regulations and laws; Demonstrated good understanding of clinical trial start-up and contracting process, and relevant clinical operation practices; Minimum of 5 years of contract and budget management experience; 百济神州全球胜任力 当我们通过以下十二项全球胜任力,展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时,我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明: 百济神州致力于尊重和保护您的个人信息权利,并承诺依据合法、正当、必要和诚信的原则处理您的个人信息(包括个人敏感信息 )。 由于百济神州在全球范围内开展业务,我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家(例如:美国)的服务器和数据库中,详情参见百济神州《求职者隐私政策》(百济神州官网 - 隐私政策 - 求职者隐私政策)。 如您主动向我们提供您的简历信息或其他个人信息,则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的,请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.
任职要求
. The Contracts Manager will identify clinical site contracts related issues and works together with other team members to propose and implement solutions.
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