Sr.Contract & Operation Analysis Expert
上海康德保瑞医学临床研究有限公司
- 公司规模：150-500人
- 公司性质：合资(欧美)
- 公司行业：医疗/护理/卫生
职位信息
- 发布日期：2015-05-23
- 工作地点：上海
- 招聘人数：若干
- 职位月薪：面议
- 职位类别：医药技术研发管理人员
职位描述
? Responsibility (JD) as below:
1. Review, negotiate and finalizing agreement related to clinical trial including but not limited to investigator agreement, CDA, MSA, CRO contract.
2. Review hospital Confidentiality agreement, Inform Consent Form and other ancillary contract to ensure the consistency between hospitals/trials in terms of terminolo-gy/content, grant fees, indemnity term and other specifications.
3. Communicate closely with legal and compliance functions to review and analyze contractual terms and conditions in accordance with Novartis policy, SOP and relevant regulatory requirement. Assess risks of budget and legal provisions together with legal and compliance functions (where applicable) and communicate them to stakeholders.
4. Remains responsibility of contract lifecycle management. Set up and maintain contract (and contract lifecycle) tracking system.
5. For outsourcing project, review the proposal from CRO and ensures scope of work is in line with needs of outsourcing activities. Negotiate costs, terms and conditions of the contract.
6. Reporting and analyzing contractual operational data, benchmark best practice on trial execution within GMO
7. In accordance to company’s policy, compliance, SOPs. Support operational excellence, efficiency. Such as productivity, saving, cost-effectiveness in GMO team.
8. Mentor and train new team member if any.
9. Compliance with local regulations, GCP, Novartis SOP and the protocol requirement during the contract review process.
1. Review, negotiate and finalizing agreement related to clinical trial including but not limited to investigator agreement, CDA, MSA, CRO contract.
2. Review hospital Confidentiality agreement, Inform Consent Form and other ancillary contract to ensure the consistency between hospitals/trials in terms of terminolo-gy/content, grant fees, indemnity term and other specifications.
3. Communicate closely with legal and compliance functions to review and analyze contractual terms and conditions in accordance with Novartis policy, SOP and relevant regulatory requirement. Assess risks of budget and legal provisions together with legal and compliance functions (where applicable) and communicate them to stakeholders.
4. Remains responsibility of contract lifecycle management. Set up and maintain contract (and contract lifecycle) tracking system.
5. For outsourcing project, review the proposal from CRO and ensures scope of work is in line with needs of outsourcing activities. Negotiate costs, terms and conditions of the contract.
6. Reporting and analyzing contractual operational data, benchmark best practice on trial execution within GMO
7. In accordance to company’s policy, compliance, SOPs. Support operational excellence, efficiency. Such as productivity, saving, cost-effectiveness in GMO team.
8. Mentor and train new team member if any.
9. Compliance with local regulations, GCP, Novartis SOP and the protocol requirement during the contract review process.
公司介绍
WuXi PRA Clinical Research (Shanghai) Co., Ltd. offers comprehensive Phase I-IV clinical trial services in Mainland China, Hong Kong and the Asia region. With 5 offices and staff based in 17 cities across China, WuXiPRA’s locally based project teams operate with the support of PRA’s global resources, clinical research expertise, global technologies and SOPs. This centralized operational approach promotes higher quality and outstanding client service. WuXiPRA has invested significantly in staff focused on CFDA regulatory expertise, project management and clinical informatics resources, as well as other support services, including RPS embedded strategic outsourcing.
上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。
上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。