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【招聘信息16241】精鼎医药研究开发(上海)有限公司

(2016-4-21)

 

精鼎医药研究开发(上海)有限公司招聘

发布时间: 2016-04-20  信息来源: null  作者: 校级管理员ltt 

 

一、公司简介:

精鼎医药研究开发(上海)有限公司(PAREXEL International),成立于1982年,是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国,分支机构遍布欧、美、亚、大洋四大洲,且于亚洲13个国家和地区设立了分支机构,致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成,服务团队集合各种不同专业领域的人才。

服务内容包括:    新药开发策略的拟定与计划     国际临床试验规划执行及整合     临床试验的监测、临床试验数据处理     临床研究统计分析     临床试验总结及统计报告     临床试验稽核服务     新药查验登记事务     国际临床试验相关法规咨询等。

精鼎医药(PAREXEL International)由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成,服务团队集合各种不同专业领域的人才,包括:药理、毒理、分子生物、生物化学、生物统计、新药研发、临床医师、临床研究、药物法规、药物管理、项目管理及临床试验等等。欲了解更多公司信息,请访问:http://www.parexel.com

二、福利政策:

精鼎医药(PAREXEL International)重视与客户的承诺,更重视人才的培育和养成,我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境,期许同仁与公司一同成长,迈向未来。

l        保险类:     社会保险(依照国家规定)及住房公积金       团体保险(包括寿险、意外暨医疗保险)     补充商业医疗保险       补充住房公积金

l        制度类:

*     学习发展计划(Learning & Development):针对个别员工之专业及兴趣,设计符合其个人之生涯规划

*     完整的教育训练:每年公司均针对所有员工,提供完整之教育训练

*     顺畅的升迁管道及可转调其它部门;如有职缺,亦可申请调至海外各子公司

l        /休假制度:

*     第一年即享有14天带薪年假,后续年休假天数依据服务年资及公司制度而定

*     一年可享12天不扣薪病假

l        员工旅游,年度体检

精鼎医药研究开发(上海)有限公司2016年职位说明

一、职位名称:Statistical Programmer I(统计编程师)-沈阳、成都

职位说明:

The Statistical Programmer works closely with Data Operation groups to support various programming activities related to the statistical analysis and reporting of clinical study data.

Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required, Use efficient programming techniques to produce high quality derived datasets, tables, figures and data listings.

资格要求:

l        Educated to BS or above degree level in the relevant discipline is preferred or equivalent work experience. (Statistics, Pharmacy, Mathematics, Applied Mathematics, Computer Science, Biological science, or other health-related discipline preferred)

l        Experience in SAS

l        Good in written and oral English

l        Demonstrate ability to learn new systems and function in an evolving technical environment

l        Attention to detail

二、职位名称:Statistical ProgrammerIntern(统计编程师实习生)-沈阳

职位说明:

Deliver best value and high quality service

Ensure quality control (QC) on all process and technical activities related to derived dataset, table,listing, and figure programming in accordance with corporate quality standards,WSOPs/Guidelines, ICH-GCP and/or other international regulatoryrequirements are performed.

Assist in the coordination of project start-up activities, including Unix/PMED project area set-up,creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and requireddocumentation.

Assist in the production and QC of derived dataset specifications, programming specifications, andother process supporting documents.

Use efficient programming techniques to produce derived datasets, tables, figures and data listingsof any complexity and QC low-medium complexity derived datasets, tables, figures and datalistings

Check own work in an ongoing way to ensure first-time quality.

Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines toensure traceability and regulatory compliance.

Proactively participate in quality improvement initiatives.

Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local andinternational regulations and participate in internal/external audits and regulatory inspections asrequired

Develop wider knowledge of SAS and other relevant programming languages and processeswithin the GRO, Biostatistics, and Medical arenas.

Provide relevant training and mentorship to staff and project teams as appropriate.

Assist project teams in the resolution of problems encountered in the conduct of their daily work.

资格要求:

l        Educated to BS or above degree level in the relevant discipline is preferred or equivalent work experience. (Statistics, Pharmacy, Mathematics, Applied Mathematics, Computer Science, Biological science, or other health-related discipline preferred)

l        Experience in SAS

l        Good in written and oral English

l        Demonstrate ability to learn new systems and function in an evolving technical environment

l        Attention to detail

三、职位名称:Clinical Research Associate(临床监察员)-长春、成都、北京、上海

职位说明:

Assume the ability to meet the requirements of a CRA I with a high degree of proficiency andautonomy

Take responsibility for specific tasks on projects, or acts as the main CRA contact on individualprojects

Train team members on selected tasks

Keep manager informed about work progress and any issues to avoid surprises.Requires someinteraction / supervision by Manager or assigned mentor.

Build relationships with investigators and site staff

Participate in Investigator and other external or internal meetings as required

Arrange on-site visits and logistics (e.g. travel arrangements)

Perform on site visits in accordance with the monitoring plan

Conduct on-site study-specific training (if applicable)

Perform site facilities inspection

Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocolviolations

Monitor and maintain ICH-GCP compliance

Responsible for the completeness and quality of the on-site files

Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site,

Protocol Deviations concerns, quality issues etc., items that require face to face interaction)

Collect SRP documents during QV and other visits as needed

Establish site recruitment plan in collaboration with site during Qualification Visit; follow-upand update at Initiation Visit and Monitoring Visit

Update all relevant tracking system on an ongoing basis

Collaborate with CMA on site issues/actions

Generate visit/contact report in accordance with monitoring plan

Code and scan Central File documents where applicable

Ship relevant wet-ink signature documents to the Assistant or back to the site

Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead

Attend audits / Regulatory Inspection if requested

资格要求:

Strong computer and internet skills including knowledge of MS-Office products such as Excel,Word

l        Strong regulatory knowledge including GCP

l        Excellent interpersonal, verbal and written communication skills

l        Sound problem solving skills

l        Ability to successfully work in a (‘virtual’) team environment

l        Sound presentation skills

l        Consultative skills

l        Client focused approach to work, ability to interact professionally within a client organization

l        Ability to prioritize multiple tasks and achieve project timelines

l        Able to take initiative and work independently

l        Sense of urgency in completing assigned tasks

l        Able to travel a minimum of 65% on average

l        Holds a driving license where required

l        Effective time management in order to meet daily metrics or team objectives

l        Shows commitment to and performs consistently high quality work

四、职位名称:Biostatistician(生物统计师博士学历)-沈阳、成都、北京、上海

职位说明:

Production and/or QC of derived datasets and both simple and advanced statistical outputsusing efficient programming techniques.

Understand and apply moderately advanced statistical methods.

Coordinate and lead a project team to successful completion of a project within given timelinesand budget.

Interact with clients as key contact with regard to statistical and contractual issues.

Assist in the production of analysis plans, statistical reports, statistical sections of integratedclinical reports and other process supporting documents.

Check own work in an ongoing way to ensure first-time quality.

Provide training in statistical analysis to internal clients.

Proactively participate in and/or lead process/quality improvement initiatives.

Mentor and train junior members of the department

Support of Business Development, e.g. by attending and preparing bid defense meetings.

Travel to, attend and actively contribute to all kind of client meetings as appropriate (e.g.Discussing analysis concepts, presenting and discussing study results)

Additional responsibilities as defined by supervisor/mana

资格要求:

l        Good analytical skills

l        Good Project Management skills

l        Professional attitude

l        Attention to Detail

l        A good understanding of statistical issues in clinical trials

l        Prior experience with SAS Programming required

l        Ability to work independently

l        Good mentoring / leadership skills

l        PhD in Statistics or related discipline, MS in Statistics or related discipline

五、职位名称:Drug Safety Associate(药物安全专员日语)-沈阳

职位说明:

Captures and assesses single adverse event reports associated with client products on a worldwide basis on the client’s Drug Safety database, in accordance with international and local regulatory requirements

Principal Functional Responsibilities:

Performing clear and accurate data capture of Individual Case Safety Reports (ICSRs) (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases; and veterinary cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of ICSRs in accordance with client conventions/guidelines and Standard Operating Procedures

Reviewing ancillary documentation accompanying ICSRs and identifying the relevant information for processing and electronic capture on the client’s safety database

Maintaining an excellent knowledge of data capture conventions and guidelines, client’s procedures and international drug safety regulations

Maintaining a good working knowledge of the AE safety profile of assigned drugs and labeling documents

Ensuring MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”

Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting

Interacting with internal or external contacts to resolve issues related to the processing of ICSRs

Responding to clients/customers in a timely manner

Performing triage of literature abstracts and/or full articles for validity

Performing single case creation/initiation in the safety database

Mentoring new recruits in the team, if required

Identifying areas of concern within the team and raising the issues with the Project Manager

Maintaining an awareness of the performance metrics measured by client and striving to remain within established limits

Note: The above statements describe the general nature and level of work being performed, and are not an exhaustive list of all responsibilities required for the position.

资格要求:

l        Degree in Science: The minimum qualification required would be a University degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)

l        Good knowledge of medical terminology

l        Fluency in written and spoken English and Japanese

l        Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (Word/Excel/Power Point)

l        Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text

l        Ability to evaluate data and draw conclusions independently

l        Typing and transcription accuracy

六、职位名称:Clinical Data Analyst(临床数据分析员)-沈阳、上海、台北

职位说明:

Responsible for completing assigned data processing activity including:

Data validation and cleaning

Generation of data queries

Generation of simple and routine study reports

Supporting database QC activities

Demonstrates competence while performing a limited number of activities including:

User Acceptance Testing

Data validation and cleaning

Generation and integration of data queries

Data reconciliation tasks

Identifying and reporting protocol deviations

Support site monitoring personnel to retrieve missing data as required

Provide work status updates regularly to direct supervisor

资格要求:

l        Medical related or Data Management are preferred.

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