自贡招聘

  Principal Accountabilities:  

• Provide input in the development and/or development of clinical trial related documents including but not limited to: Protocols, case report forms, informed consents, study timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and initiation/investigator meeting slide presentation.

• Collaborate with COPM for country and center feasibility assessment. Assist in identifying suitably qualified trial sites within a specified geographical area. Manage CTB/EC/HGR submissions and approvals, assist COPM maintain study specific tracking tools for CTB/EC/HGR management. Manage contract between Servier and study sites or contract between Servier and relevant venders if necessary, such as CRO, SMO, Patient referral company, etc.

• Conduct qualification, initiation, interim, close out and remote visits and provide visit reports as per monitoring guidelines. As the delegated person, to perform Co-monitoring visit or Accompany field visit in the trial sites with the assigned regional/contract CRAs as required, and provide visit reports as per related guidelines.

• Maintain required documentation in the Investigator File and provide required documentation to the clinical team for the Trial Master File.

• Maintain study specific tracking tools. Ensure the trial site complies with the study protocol, GCP and applicable regulatory requirements.

• Control the integrity of the data produced by trial sites through review of case report forms, source documents/medical and pharmacy records. Ensure review is conducted in accordance with the agreed study timelines.

• Verify patient eligibility, communicate and document protocol violations, non-compliance and poor performance and assure that corrective action is taken, after discussion with the COPM within the timeframe appropriate to the degree of deviation from the study protocol.

• Assist COPM manage SUSAR and SAE reports, and ensure appropriate action is taken at the study site in accordance with the appropriate Policies, Standard Operating Procedures (SOPs), study specific requirements, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and applicable local regulations.

• Provide study site updates to the COPM according to study monitoring guidelines.

• Attend regular Project discussion meetings, Investigator Meetings. Manage and track invoices of trial sites or relevant study venders, and resolve any issues that may evolve.

• Assist in managing investigational products and materials supplies at the country (where applicable) and trial sites level, keeping sites informed of drug lots/batches and expiration dates. Assist trial sites in meeting project timelines, and proactively inform COPM and team of corrective action, as necessary. Assist in the preparation for site audits and inspections and participate in the inspections and in responding to any issues identified within the timeframe specified.

• Maintain/develop a good level of scientific knowledge within the Project’s therapeutic area. Maintain good communication between study site, Key opinion leaders, clinical team and relevant study venders.

                        

 

  

Knowledge/ Academic Qualification:

  

1. Bachelor’s degree (or equivalent) in a science or healthcare-related field required. Master’s or other advanced degree preferred.

2. Excellent knowledge of clinical pharmacology from PK, Phase I – III.

3. Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment.

    

   Skills:

   Proficient in e-CRF, IVRS, and project management tools

    

   Experience:

                

1. 5 years of CRA experience, Project leader experience or partial project management experience preferred.

2. At least 2 years of CRA experience in Oncology clinical trial, hematologic cancer preferred (optional requirement).

    

      

施维雅是一家由非盈利性基金管理的国际制药公司，总部位于法国叙雷讷。施维雅在149个国家拥有强大的国际业务，在全球共有21,700名员工；2017年营业额为41.52亿欧元。作为一家完全独立的企业，集团将其25%的营业收入投入到药品研发工作中（不含仿制药），并将其所有利润用于企业发展。在心血管疾病、免疫炎症疾病、神经变性疾病、癌症和糖尿病等五个卓越领域持续不断的追求创新，是施维雅持续增长的动力。施维雅还提供药物开发以外的eHealth解决方案。

1979年，施维雅成为首批进入中国的跨国企业之一。施维雅在中国注册有14种高品质创新药物；6大区域办公室是分设在北京、南京、上海、杭州、武汉和广州；拥有2070名员工，业务覆盖29个省市地区，施维雅中国已经成为集团***的专业队伍；承诺关爱40年，施维雅中国已经在心血管、糖尿病等疾病领域，稳居行业领先地位；每天为300万中国患者提供治疗药物和方案。施维雅中国将不断加强在糖尿病、高血压、心衰等领域的产品组合，提供高质量创新产品和综合治疗方案；并将持续与行专业协会、学会合作，提升对慢病患者的诊疗水平。

作为施维雅中国的一部分，施维雅（天津）制药有限公司于2000年在天津经济技术开发区注册成立，并投资建立现代化工厂，于2002年正式投产。目前，施维雅天津工厂正在进行全新制剂车间的扩建。施维雅中国研发中心成立于2001年。该研发中心负责在大中华地区开展地方性与国际性的临床研究。自2018年开始，施维雅致力于在中国寻找本土在研新药项目，审慎评估调研后的合适项目将引进总部持续开发合作。

作为一家由非营利基金会管理的跨国制药企业，施维雅早在1979年，中国改革开放之初，就在中国设立分支机构，服务中国13.9亿人民。扎根中国40年，施维雅始终聚焦中国需求巨大的疾病领域，提供全方位创新健康解决方案。目前，中国已经成为施维雅集团营业额排名***位的分公司。施维雅坚持对中国患者的长期承诺，以患者的健康需求为所有业务开展的核心考量。施维雅中国目前拥有2,000余名员工，业务覆盖29省市地区；成为施维雅全球***的一支专业队伍，向中国患者提供14款优质创新药物。40年来，施维雅中国聚焦中国高发的慢性疾病领域，在跨国制药企业中排名慢性疾病领域排名第6，成为慢病管理的有力践行者。

创新是促进施维雅中国不断发展的动力源泉和策略重点。在施维雅中国，创新不仅体现在产品研发层面，更展现在数字化医疗诊断治疗工具和平台的积极拓展、为专业医护人员和患者提供更为便捷的数字化健康咨询和综合性健康管理方案。通过每位员工的行动，施维雅中国帮助中国患者获得高品质的医疗健康服务。

施维雅积极适应快速变化的行业环境，始终采取负责任的行动；并遵守对患者和患者协会，对医疗卫生专业人士和机构，对员工，对合作伙伴、供应商和竞争对手，对公共机构，以及对社会与环境的相关义务。施维雅中国每一位员工承诺遵守“职业道德准则”，并依据这些准则开展日常工作，维护患者利益。