南京招聘

Primary Purposes of Position:

An experienced role.

1. Conduct clinical trials for assigned in compliance with local regulations, ICH-GCP guidelines and Ipsen SOPs, to ensure all responsible studies been completed accordance with the company’s requirement.

2. 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.

3. Drive quality standards by acting as a mentor and providing support to less-experienced colleagues.

4. Support line managers by performing specific operational tasks as required.

5. Support project managers for assigned clinical trials as required.

Main Duties to be performed:

l Participate in the identification and evaluation of high quality study sites and investigators.

l Conduct the site selection including the feasibility questionnaire and pre-study visit.

l Conduct study site documents preparation and EC submission.

l Organize and participate in investigator meeting, initiate study site, and train site staff study specific issues. Complete regulatory document collection.

l Monitor clinical studies according to the monitor plan requirement, ensuring regular contact with investigator sites, identifying and solving issues in study progress and following up as required with investigator and sponsor files and study material.

l Meet the agreed timelines of CRFs and Queries, sending information to data-management department or CRO.

l Close the investigator sites as required.

l Complete visit report within required timeline, for example, using paper or in the Hermes system, send feedback letter to the clinical site investigators timely after visit and regularly check Hermes for quality and accuracy.

l Complete the study site payment application according to the contract and follow up the invoice collecting from the related sites.

l Maintain, update and archive all clinical trial files on time.

l Ensuring all clinical trial SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOPs, and all aspect related to pharmacovigilance are performed in right manners.

l 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.

l Coordinate and manage the CRO relationship if applicable.

l Mentor and support less-experienced colleagues.

l Conduct Co-monitoring and ensure clinical trial quality when assigned.

l Use findings and observations from oversight activities to proactively drive higher quality standards.

l Perform designated tasks from line managers to the required standard.

l Support and coordinate project managers for assigned clinical trials as required.

l Complete all of the above activities within the framework and in compliance with Ipsen SOPs and other documentation in force within the Ipsen Group.

l Ensure Ipsen Clinical Trial Management System (CTMS) is updated in a timely manner, e.g., HERMES.

Specifics of Position:

l Life science graduate

l Relevant work experience within clinical research area

l Good knowledge of ICH GCP and local regulations

l Teamwork and collaboration with others

l Ability and willingness to adjust quickly to new situations in a continuously developing

l Initiative and continuous improvement the relevant knowledge and performances (in terms of quality, timeliness and costs)

l Strong organization and interpersonal skills

l Excellent verbal and written communication skills

l Show professional awareness and integrity

l Adequate IT proficiency

l Flexibility

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。