Clinical Trial Contract Coordinator
艾昆纬医药科技（上海）有限公司
- 公司规模：500-1000人
- 公司性质：外资（欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2022-07-14
- 工作地点：上海-浦东新区
- 工作经验：1年经验
- 学历要求：本科
- 职位月薪：9千-1.5万
- 职位类别：临床协调员
职位描述
Clinical Trial Coordinator (Contract Specialist)
负责支持CRA，进行临床试验合同的谈判，跟进合同审批。和法务部合作，更新和维护管理合同等。
Responsibilities include, but are not limited to:
? Trial and site administration:
Track (e.g. essential documents) and report; ensure collation and distribution of study tools and documents.
? Document management:
Prepare documents and correspondence; collate, distribute/ship, and archive clinical documents, e.g. eTMF; assist with eTMF reconciliation; execute eTMF Quality Control Plan.
? Site Start-Up responsibilities:
Collaborate with other country roles to provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions in a timely manner; obtain, track and update study insurance certificates.
? Collaborate with finance/budgeting representatives for budgeting, agreement and payments management:
Develop, control, update and close-out country and site budgets (including Split site budget); develop, negotiate, approve and maintain contracts (e.g. CTRAs); track and report contract negotiations; update and maintain contract templates (in cooperation with Legal Department); calculate and execute payments (to investigators, vendors, grants); ensure adherence to financial and compliance procedures; monitor and track adherence and disclosures; maintain tracking tools.
? S/AE Claim Management:
Support Financial Clinical Operation Manager(F-COM) to coordinate meetings, update and maintain tracking tools; develop and maintain settle agreements; coordinate for payments; collate, distribute/ship, and archive relevant documents.
Requirements:
1. ***本科及以上，专业不限
2. 一年以上的医疗行业合同谈判与协调的工作经验; 有CTA/CRC/SSU/CRA/法务/采购等相关工作经验优先考虑
3. 良好的英语能力，可进行基本对话，通过CET-6者优先考虑
负责支持CRA，进行临床试验合同的谈判，跟进合同审批。和法务部合作，更新和维护管理合同等。
Responsibilities include, but are not limited to:
? Trial and site administration:
Track (e.g. essential documents) and report; ensure collation and distribution of study tools and documents.
? Document management:
Prepare documents and correspondence; collate, distribute/ship, and archive clinical documents, e.g. eTMF; assist with eTMF reconciliation; execute eTMF Quality Control Plan.
? Site Start-Up responsibilities:
Collaborate with other country roles to provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions in a timely manner; obtain, track and update study insurance certificates.
? Collaborate with finance/budgeting representatives for budgeting, agreement and payments management:
Develop, control, update and close-out country and site budgets (including Split site budget); develop, negotiate, approve and maintain contracts (e.g. CTRAs); track and report contract negotiations; update and maintain contract templates (in cooperation with Legal Department); calculate and execute payments (to investigators, vendors, grants); ensure adherence to financial and compliance procedures; monitor and track adherence and disclosures; maintain tracking tools.
? S/AE Claim Management:
Support Financial Clinical Operation Manager(F-COM) to coordinate meetings, update and maintain tracking tools; develop and maintain settle agreements; coordinate for payments; collate, distribute/ship, and archive relevant documents.
Requirements:
1. ***本科及以上，专业不限
2. 一年以上的医疗行业合同谈判与协调的工作经验; 有CTA/CRC/SSU/CRA/法务/采购等相关工作经验优先考虑
3. 良好的英语能力，可进行基本对话，通过CET-6者优先考虑
公司介绍
IQVIA（纽交所代码：IQV）是全球专注生命科学领域的高阶分析、技术解决方案和临床研究服务供应商。IQVIA利用深入分析、前沿技术、大数据资源和广泛领域的专业知识，智能连接医疗生态的各个环节。IQVIA Connected Intelligence？快速敏锐地为客户提供强大的数据洞察，帮助客户加速创新医疗的临床开发和商业化进程，以更好的医疗成果惠及患者。IQVIA拥有约72,000名员工，足迹遍布100多个国家/地区。
IQVIA拥有多元化的加强型隐私技术和保障手段，能够在保护个人隐私的同时对信息进行管理和分析，帮助医疗利益相关方有效开展精准疗法，获得更佳的疗效。这些洞见和能力能够帮助生物科技、医疗器械、制药公司、医学研究者、政府机关、支付方以及其他医疗利益相关方，获得对疾病、人类行为和科技进步更深入的理解，共同朝着治愈各类疾病的方向迈进。
IQVIA拥有多元化的加强型隐私技术和保障手段，能够在保护个人隐私的同时对信息进行管理和分析，帮助医疗利益相关方有效开展精准疗法，获得更佳的疗效。这些洞见和能力能够帮助生物科技、医疗器械、制药公司、医学研究者、政府机关、支付方以及其他医疗利益相关方，获得对疾病、人类行为和科技进步更深入的理解，共同朝着治愈各类疾病的方向迈进。
联系方式
- Email：chinacampus@iqvia.com
- 公司地址：越华路112号珠江国际大厦
- 电话：13522411136