“诺华（中国）生物医学研究有限公司”，是一个在上海及北京两地都有办公室的国际医药研发中心。目前临床前实验部门要招聘实习生以及应届毕业生。
招聘时间：2010年6月24日（下周四）晚6:30
招聘地点：北京大学医学部逸夫教学楼509教室
工作地点：在东三环的财富中心
说明：我们首选的应聘方式是在公司网页上上传简历。（For application please visit our website: ca***.cn[点击查看]> choose 诺华生物科技研究院 -> click on “Clinical Trial Leader II” 68131BR or "Internship for Clinical Trial Team" BR)
如果学生无法登录网站，也可将简历发送至recruit_cnibr.phcnzj@
职位一、Clinical Trial Leader
We are looking for a Clinical Trial Leader who will be responsible for the planning and implementation of all operational aspects of assigned Translational Medicine studies (e.g. medium to high complexity studies; first in man patient studies, multi-centers studies, mechanistic studies) from synopsis to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).
1.Accountable for the writing of clinical protocols and related documents in collaboration with the Clinical trial Team (CTT): lead the clinical trial protocol development process; contribute to the operational and scientific input given for the development of trial-related documents and processes which reside in other line functions.
2. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: chair CTT meetings (as needed), report study progress and issues to CTT and TM-SO Management; lead trial level interactions with internal line functions and external CROs e.g. those providing monitoring and site management services.
3. Function as a Lead CTL on studies for Full Development and assist in the coordination of TM related submission documents.
4. Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs
5. In collaboration with CRO management, CTT and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Initiation meeting
6. Support the CRA on study related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility
7. Responsible for set up and maintenance of the Trial Master File for assigned studies.
8. Regularly update all trial information databases in order to manage accuracy of information
9. Approve for all necessary center payments as per financial agreements.
10. In collaboration with the TME and CTT, lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and interpretation including the development of first interpretable results, clinical trial reports, publications and internal/external presentations.
11. Co-ordinate pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved.
12. Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients.
13. Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned.
14. Provide TM-SO expertise to other departments and line functions e.g. Drug Supply Management (DSM), through e.g. cross-functional working groups or TM Initiatives.
15. Contribute to talent and career development of TM staff through active participation in on-boarding, training and mentoring activities.
Minimum requirements:
1. BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD.
2. Fluent English (oral and written). Knowledge of a second language is desirable.
3. Gained relevant experience (preferred at least 2 years) in Translational medicine, Clinical Research or Research Nurse experience (CRO, academic institution, hospital or industry), as judged from CV/interview
4. Potential to cope with both scientific aspects and operational tasks in a multidisciplinary organization (teamwork).
5. Knowledge of drug development process.
6. Capable of clear written and verbal expression of ideas, an active/proactive communicator..
For application please visit our website: ca***.cn[点击查看]> choose 诺华生物科技研究院 -> click on “Clinical Trial Leader II” 68131BR
职位二、Internship for Clinical Trial Team
We are looking for an intern who will assist in the operational and logistical aspects of clinical trials according to GCP (Good Clinical Practice) and relevant Novartis procedures and assist in delegated tasks to support the clinical trial team, ensuring that all essential documentation is collected, maintained and filed during the study.
The major responsibilities are:
1. Provide support to the Clinical Trial Leader (CTL) with many of the tasks involved with the smooth running of clinical trials in compliance with Novartis processes. Collaborate with the CTL in taking action to address issues as they arise.
2. Help manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations. Identify issues and take appropriate corrective action as necessary.
3. Translate study documents from English to Chinese and Chinese to English.
4. Liaise with contract organisations, vendors and other suppliers of project support services to ensure study deliverables are met e.g. contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups.
5. Provide input on agendas, create materials, liaise with meeting planners and coordinate logistics for key meetings e.g. internal CTL meetings or external investigator meetings. May attend and present at these meetings as appropriate.
6. Help ensure accuracy of clinical trial databases and resource tracking tools providing information and following up questions as necessary. Help check for discrepancies and take actions to correct as necessary.
7. Identify areas for process or technology improvements with regard to tasks undertaken within the role; propose and complete a project to enhance efficiencies and promote standardization across the organization based on this.
8. Assist in the forecasting, identification and ordering of clinical trial supplies. Recognize problems or delays and take action to prevent or address issues. Inform relevant project members as appropriate.
9. Responsible for setting up and maintaining Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines.
10. Attend Investigator/Site Initiation Meeting and First Dose/Monitoring Visit where required, and assist the CTL in organizing and conducting the meetings
Minimum requirements:
1. Bachelor’s degree or in the final year of a Bachelor’s degree program (for undergraduates), in life sciences.
2. Fluent English (oral and written)
3. Good organizational and interpersonal skills.
4. Attention to details.
5. Capable of clear written and verbal expression of ideas.
6. Ability to work independently and manage multiple priorities.
7. Computer literate. Good knowledge of Microsoft Office (Word, Excel, PowerPoint).
8. Some knowledge of clinical trial design, execution and operations would be beneficial.
For application please visit our website: ca***.cn[点击查看]> choose 诺华生物科技研究院 -> click on “Intern for Clinical Trial Team” 69164BR
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