南京招聘

Trial Master File (TMF) management (External CRO or internal) –

?Be responsible to set up and administrate the Ipsen eTMF or set up the paper TMF files and to prepare the study specific TMF oversight plan.

?To maintain and complete the paper and/or electronic TMF for Ipsen documents and appropriate filing documents (See responsibilities in the TMF Procedure)

? Identify, request and ensure delivery of outstanding and outdated documents from CROs/vendors.

? Identify and prepare documents for country requirements in the framework of regulatory submissions as needed.

?Periodically during study course and at the end of the study according to the study eTMF oversight plan, review overall study TMF (whatever format or location e.g. CRO e-TMF/Ipsen e-TMF or paper TMF) for organization, quality, and for completeness as per ICH GCP requirements. Review and QC check of the TMF to ensure their quality and completeness in view of audit or / and inspection or archiving

?Be responsible to chase up the CRO/vendors and Ipsen teams as appropriate for any missing documents until resolution.

? Responsible for managing the Archiving of the eTMF

Follow up and review of financial documents, in collaboration with Global Clinical Project Manager (Ipsen or partner GCPM):

? Create and update financial information within SAP (Internal Order, Purchase order, goods receipt & invoices)

? Create Commitment Requests within the K2 tool

? Create and update financial trackers

? Management of invoices, including review against contracts and study progress for GCPM approval, track and follow up until payment is made

?Help to prepare forecast and assist at quarterly review meetings of study budget with GCPM and local finance controlling department

?Complete files for Transparency Office requirements (France, EFPIA, US) or receive and check against study activities in collaboration with the GCPM, and forward files from Service providers and final uploading into Ipsen Transparency Tool (Collect)

Clinical operations activities tracking & coordination:

? Follow up on execution/signature of Clinical contracts and populate iCap with finalised contracts.

? Clinical supplies coordination (K2 dispatch order) when there is no IVRS; Internal Meeting preparation and co-ordination

? Tracking of Ipsen Oversight of a study (e.g. CRO monitoring visit reports…)

? Study Insurances management: requests, follow-upand renewals

? Legal administrative documents obtention and follow up as required (POA, LOA, CDA’s, Kbis…)

?Set up, and update of shared study team electronic site (SharePoint or other tool) - Mailing of study documents by express courier, as requested

? Organising appropriate logistics for any Ipsen Sponsor meetings (invitation/room booking/lunch order...)

?Assist the GCPM and CL as appropriate and as needed in various study management and monitoring activities, including liaison with, monitors, CROs, drug vendors, central laboratories and other vendors for study related tasks.

Clinical Trial Management System Data Entry

?Responsible for data entry and status updates within the CTMS for the assigned studies, with support of the CL or GCPM if needed

Others missions to the position

?To perform any other activity as may reasonably be required from time to time to ensure the accurate, quality and timely execution of clinical studies

?Complete files for Transparency Office requirements (France, EFPIA, US) or receive and check against study activities in collaboration with the GCPM, and forward files from Service providers and final uploading into Ipsen Transparency Tool (Collect)

Clinical operations activities tracking & coordination:

? Follow up on execution/signature of Clinical contracts and populate iCap with finalised contracts.

? Clinical supplies coordination (K2 dispatch order) when there is no IVRS; Internal Meeting preparation and co-ordination

? Tracking of Ipsen Oversight of a study (e.g. CRO monitoring visit reports…)

? Study Insurances management: requests, follow-upand renewals

? Legal administrative documents obtention and follow up as required (POA, LOA, CDA’s, Kbis…)

?Set up, and update of shared study team electronic site (SharePoint or other tool) - Mailing of study documents by express courier, as requested

? Organising appropriate logistics for any Ipsen Sponsor meetings (invitation/room booking/lunch order...)

?Assist the GCPM and CL as appropriate and as needed in various study management and monitoring activities, including liaison with, monitors, CROs, drug vendors, central laboratories and other vendors for study related tasks.

Clinical Trial Management System Data Entry

?Responsible for data entry and status updates within the CTMS for the assigned studies, with support of the CL or GCPM if needed

Others missions to the position

?To perform any other activity as may reasonably be required from time to time to ensure the accurate, quality and timely execution of clinical studies

Qualifications

? Experience in Clinical Operations area related work is preferred. Scientific background preferred

? Board-certification in Medical Oncology and/or Internal Medicine (Oncology Therapeutic Area) ; Nuclear Medicine, Medical / Radio-Oncology and/or Internal Medicine (Radiopharmaceutic Oncology Therapeutic Area); Internal Medicine with solid experience in Neurology and/or Neurology (Neurology Therapeutic Area)(or comparable international other qualifications) is preferred

? Substantial practical and academic experience (preferably with clinical trial experience); state-of-the-art medical, scientific knowledge; and track record of successful publications (preferably with translational medicine experience) in Oncology (and/or Gyneco-Oncology and Senology) and/or Internal Medicine , and/or Neurology (dependant on specific role’s Therapeutic Area focus)

?Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management

? Previous experience directly and independently leading projects and/or a team of professionals

?Previous experience on transversal projects (with other functions) and multiple therapeutic areas and stages of drug development, exhibiting the ability to influence others (above and beyond ones’ own function)

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。