长沙招聘

汇报人：Business Operations Lead

Position Purpose:
To provide administrative, technical and logistical support to ensure timely and efficient execution of clinical trials, and compliance of ICH-GCP, SOP, and regulatory regulations

Major Duties of CTA:
• Support the tasks below for assigned project throughout the study:
Responsible for Trial Master File (TMF) maintenance in accordance with ICH-GCP and SOPs (ELARA scanning, indexing and QC within prescribed timelines)
Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner
Attends appropriate training programs and project teleconferences as applicable.
Supports on clinical trial related document submission.
•Study Start-Up
Supports and coordinates the clinical trial application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.
Coordinates and applies for export/import license of lab kits, equipments, and specimen, if applicable.
Responsible for preparation, compilation, accuracy review and correction of Investigator Initiation Package (IIP) documents and obtaining approval(s) to ensure drug release in the defined timelines.
Supports for preparation of site initiation packages (e.g. SMF)
Supports for collection of site contact information to DSU for SUSAR distribution to investigators
• Study Conduct
Supports and coordinates the clinical trial application for amendment and progress report to ethics committee and regulatory authority, if applicable, and obtain approval within required timeline.
Ensures along with the CRA the reconciliation of Trial Master File and the Site Master File on a periodic basis.
Responsible for revision of all the applicable documents as and when required in a timely manner (e.g. FDA 1572 form, financial disclosure form)
Maintains / develops local tracking spreadsheets for study-related documents, data, tasks and activities, as applicable.
Assists in preparation of newsletters and other study-related documents.
Assists CRA for the responsibility of tracking, distribution and filing of clinical trial documents/information (e.g. paper CRFs, DCFs ) with quality review for accuracy and completeness.
• Study Close-Out
Ensures along with the CRA the reconciliation of Trial Master File and the Site Master File
Supports Study Manager and CRA for final archive of study-related documents
Other responsibilities of the CTA:
Demonstrates and promotes Pfizer global value system across all interactions.
Complies with Pfizer Policies, SOPs & IGs and local regulations during various projects related transactions
Supports Lead of Clinical Quality for quality improve related initiatives
Ensures P2L training 100% completion.
Ensures GCOLT Metrics Compliance pertaining to CTA role.
Provides back-up coverage for other CTA as necessary.
Mentors new CTA when applicable (apply for B4 level)
Supports Lead of Business Operations for production and tracking of trial metrics measurements.
Supports Study Manager for coordinating with sites for finalizing budget worksheets and contractual agreements (e.g. FCPA clauses).
Supports Study Manager and CRA to track study budget in country and site level as applicable.
Coordinates the payment request for project related activities and maintains the tracking report
Maintains and ensures the availability of inventory for all non drug supplies.
Provides logistic and administrative support to project teams.
Supports CRA on SUSAR distribution to EC
Takes SME role for each functional support and leads any SOP updates learning in the team and new staff orientation as appropriate

Training & Education
Required:
• College degree or above
• Good English skills in writing and reading
• Proficiency in basic computer literacy (e.g. Microsoft word, Excel and PowerPoint)
• 3 years of clinical research experience(apply for B4 level)
Preferred:
• Science Background
• University Graduate
• Experience in clinical trial administration

Training and Relevant Experience
Preferred
• Knowledge of ICH GCP and local regulations
• Experience in management of clinical trial and/or regulatory documents
• Knowledge of application used in the clinical trials .

简历投递邮箱：hrrecruitment@pfizer.com

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.