南京招聘

Responsibilities:
Primary Purposes of Position:
-To conduct clinical studies in Ipsen China to support company business objectives and to ensure any given trial/study conduction in accordance with protocol requirements, local regulations, Good Clinical Practice (GCP) guidelines and SOPs.
-To ensure all studies to be conducted with the most rigorous standards of quality, timely delivery and within budget in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.

Main Duties to be performed:
-To prepare for study start-up by understanding study specific issues, informing and training investigator teams on these issues, initiating site activities including regulatory document collection and ethics committee submission and organizing and participating in investigator and monitor meetings in conjunction with other Clinical Operations personnel.
-To monitor clinical studies, ensuring regular contact with investigator sites, identifying and solving issues in study progress, verifying data, conducting on-site, in-house and co-monitoring visits in collaboration with other Clinical Operations personnel and following up as required with investigator and sponsor files and study material. To close the investigator sites as required.
-To report all visits and contacts on Hemes (Ipsen's clinical trial management tracking system), via reports and post visit letters, and with feedback to the clinical study team and regularly check Hemes for quality and accuracy.Assist with the financial follow-up of the study.
-To meet the agreed timelines of CRFs and Queries, sending information to data-management CRO.
-Maintaining, updating and archiving all clinical trial files on time
-Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOPs, and all aspects related to pharmacovigilance are performed in right manners.
-To perform various study-related functions to ensure the execution of clinical studies and any other activity as may reasonably be required from time to time.
-To coordinate and manage the CRO relationship.
-To complete all of the above activities within the framework and in compliance with R&D SOPs and other documentation in force within the Ipsen Group.

Requirements:
-Life science or medical graduate or other relevant qualifications
-Relevant work experience within clinical research area
-Good knowledge of ICH GCP and local regulations
-Teamwork and collaboration with others
-Ability and willingness to adjust quickly to new situations in a continuously developing
-Initiative and continuous improvement the relevant knowledge and performances (in terms of quality, timeliness and costs)
-Strong organization and interpersonal skills
-Excellent verbal and written communication skills.
-Show professional awareness and integrity
-Adequate IT proficiency
-Proactive approach
-Flexibility

Please send your resumes both in English and Chinese to this email: hr.china@ipsen.com.

益普生集团是一家专注在药物创新和肿瘤病学、神经科学以及罕见病学领域的国际生物制药公司。我们有完善和成功的消费者保健业务，始终致力于通过发现新的疾病解决方案来提高患者的生活质量。从家族企业到上市集团，我们已经走过90年的历史，益普生集团拥有20种产品，销往网络遍布于115个国家，并在其中30多个国家直接设立了商业公司。2019年的总销售额超过25亿欧元，其中在欧洲达到了两位数的增长，在北美增长了20%。我们专注于以Decapeptyl？为代表的肿瘤病学、Dysport？为代表的神经科学以及罕见病学为主导的专科疾病领域，且在多元健康业务领域也有卓越表现。目前我们在全球范围内拥有逾5700名员工，建立了8家研发中心和8个生产厂。值得骄傲的是，2018年我们将13.5%的销售额投入到研发。在肿瘤病学领域，我们是全球排名前14的生物制药公司。

1992年，益普生进入中国并在天津成立代表处开展业务，随后于1997年在天津华苑产业园区成立合资企业博福-益普生（天津）制药有限公司。经过了逾23年的稳健发展，中国已经成为益普生集团在全球范围的第二大市场。随着益普生集团整体发展战略的清晰化，特别是随着销售额和市场需求的不断攀升，2015年5月益普生（天津）医药商贸有限公司在天津成立。2010年4月，益普生（北京）医药商贸有限公司在北京成立，2020年4月益普生（上海）成立。

在中国，益普生借助其明星产品思密达成为了消化领域的领导企业，并且力争成为专业治疗领域内的领军者。益普生近期在中国所进行的Somatuline？和Dysport？的临床实验也推动了在专科领域特别是内分泌和神经领域的快速发展。另一个见证益普生在专科领域蓬勃发展的案例就是泌尿肿瘤类药物Diphereline？，一种服务于前列腺癌患者的领先药物。