长沙招聘

Description
Study Planning/set-up activities
§ When required, assist LTM to conduct site feasibility
§ conduct Pre-trial visits to assess the investigational staff and facilities
§ Discuss the items listed on the PAR with the investigator and other appropriate staff
§ Review the site commitment in detail with the investigator
§ Develop/adapt recruitment and retention strategy for the site
§ Ensure all required trial-related materials and supplies are provided to the investigational site
§ Ensure that the investigators send the SUA gap pack to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
§ Set up the IF and TCF
§ If needed, development of site-specific ICF
§ Ensure that the investigational staff are instructed on the requirements for proper informed consent
§ When local Ethics Committees are used, ensure that the IEC/IRB is provided with current and complete copies of all documents that the IEC/IRB requests to fulfill its obligation and obtain a copy of the valid written IEC/IRB approval and all related required documents, including the composition of the IEC/IRB
§ Obtain site related trial documents and review them for completeness and accuracy
§ Negotiate investigator budgets at site level and track the status of site CTA
§ Plan and conduct investigator and site-staff training
§ Conduct site initiation visits
§ If applicable, execute the user acceptance testing plan
§ If applicable, create site specific and monitoring tools

Monitoring activities
§ Notify the GTM and the Local CSC in writing, when a country and an investigational site is approved to receive clinical drug supplies
§ At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (e g , temperature logs, security), and returned, accurately inventoried and documented. Inform the investigational staff of the distribution process
§ Conduct monitoring visits according to the checklist of activities listed on the Monitoring Visit Report
§ Report to LTM on study site status through monitoring report and meetings
§ Document all study related communications
§ Perform SDV to ensure accurate data is recorded based if required
§ Follow up with the trial site(s) regarding completion of case report forms and data correction forms within required timeframe
§ Ensure that all AEs/SAEs/PQCs are reported within reporting timelines and documented as appropriate. For AEs/SAEs ensure they are consistent with all data collected and with the information in the source documents
§ Ensure that the investigators send the safety reports to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
§ Arrange for the appropriate destruction of clinical drug supplies
§ Ensure that the investigational staff stores the randomization codes in a limited access area that is accessible 24 hours a day and instruct them on the code-breaking procedure
§ In studies where IVRS/EDC are used, ensure that the IVRS/EDC at the site work smoothly during the study.
§ Track costs at site level and ensure payments are made with planned payment schedule
§ Ensure TCF is maintained as required and maintain IF
§ Ensure subject commitment per site is met
§ Conduct site closure visit according to the checklist activities listed on the site closure report
§ If applicable, remind the investigator to notify the IEC/IRB of the site closure
§ Ensure the IF is complete and accurate
§ Provide study report synopsis to investigators, IEC/IRBs
§ Check the Site details on Appendix 1 documents and provide feedback to the LTM
§ Follow up on and resolve any pending issues, including adverse events and IFDFs one year post-trial

General activities
§ Represent the company and the organization adequately to the customers and other external parties
§ Base all actions on Credo
§ Protect the rights of others, protect privacy and company assets, particularly information as the key asset
§ Conduct business in line with the HCC, company policies and procedures, including applicable SOPs, always having the ethical aspect in mind
§ Maintain adequate communication with relevant parties within and outside the company
§ Comply with ICH-GCP and all applicable local laws and regulations
§ Actively follow trainings to ensure adequate qualification for performing job-related tasks
§ Report (suspicion of) fraud or scientific/ethical misconduct as appropriate
§ Regularly update information in applicable systems and templates
§ Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company's effort towards continuous quality improvement
§ Maintain quality standards and timelines that are consistent with business needs

Qualifications
A. Education /Training background:
Bachelor degree, background of medicine or pharmacy is preferred

B. Knowledge/Skills:
Well familiar with ICH GCP, GCP of China and applicable regulations
Well familiar with procedures of clinical R&D and regulation application

C. Job experience:
3 years clinical study experience.
Working experience in international pharmaceuticals or CRO

D. Competency:
Good communication, team working, problem identifying and solving abilities

E. Others:
Good english ablities of listening, speaking, reading and writing; same level of CET-6 or above

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国***的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。

本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。

目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。

2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。