Project Associate, Clinical Site Contracts

General Description: The Project Associate (PA) will provide administrative and project support to Clinical Site Contracts team thereby contributing to the overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs). The Project Associate is responsible for the day-to-day coordination and data entry/administration of project-specific activities. The contracting activity supported by the Clinical Site Contracts team is fast-paced, with short deadlines and quick turnaround times therefore Project Associate must be capable of managing priorities effectively, proactively communicating issues and working in a fast-paced environment and project. Essential Functions of the Job: • Provide project administration support to Clinical Site Contracts • Responsible for clinical contract management, study metric tracking and reporting. • Active participant in various study meetings. • Collect site specific contract/budget information and contribute to the maintenance of contract/budget intelligence tools. • Assist with projects supporting Cost per patient library (CPP) • Support the contract related data clean requirements within the necessary internal system including but not limited to Agiloft, CTMS, CPP library, Smartsheet, Sharepoint. • Handle hard copy signatures of Clinical Site contracts and archival • Assist with timeline management to ensure Clinical site contracts are executed in a timely manner • Prepare TMF FQC reporting • Support CBO process document maintenance • 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. • Provides support with set-up, access requests, and maintenance for project systems within Clinical Business Operations • Assists with maintaining and updating project-related data in an existing database, which may require contacting internal team members to gather information. • Generates and formats project-related data in reports and compiles data as requested. • Assists with the preparation and distribution of project-related correspondence (e.g. agendas, meeting minutes, tracking spreadsheets, newsletters and presentations). • Assist in all administrative duties related to contract signatures • Assists with development of Investigator contract amendments • Assists with potential site identification and facilitates site outreach activities for feasibility projects (e.g. CDA execution, Feasibility Questionnaire completion by sites). • Assists with translation of project documents. • Assists with the planning, organization and execution of meetings (e.g. project Kick Off meetings, internal team meetings, Client meetings). • Assists with maintaining of project team lists. • Performs other duties as assigned by management. 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: • A minimum of 1-year applicable industry or administrative experience required. • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations. • Effective verbal and writing skills; English + local language, if relevant 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. 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