精鼎医药诚聘临床统计分析师和临床监察员

1.招聘职位： Statistician（临床统计分析师）
工作内容 Department：Clinical Data Management & Statistical Analysis
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3 h& }0 N+ V7 J0 FBasic Function：This position is responsible for the development and implementation of the statistical analysis plan, working with data management to define and review the clinical database system, development of project specific standardizes programming tools and routines for analysis and is also responsible for providing the statistic and programming consulting support within the company.
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$ q$ p! |$ ?4 Y1 O% p* F- GMajor Responsibilities:Study Initiation:
1.Provide assistance to Clinical in the design of the protocol with emphasis on the statistical design consideration, sample size determination and power assessment.
2.Develop the statistical analysis plans.
3.Implement the randomization schedule required for study.
4.Work as part of the data management team in case report form development and review.
( }$ g, y; y+ O9 XStudy Operation:
1.Assist in the development and review of the clinical trial database system, structure, and validation.
/ K$ X0 h% T" f. p% Z0 ?+ z5 t2.Develop the project specific standardized programming tools and routines for analysis report from the clinical database.
# D9 P" ?7 {  C; f; o! FStudy Conclusion:
1.Apply effective programming techniques to summarize, analyze, and produce data listings and summary tables of efficacy, safety, and compliance as specified in the analysis plan.
2.Assist Clinical in consolidating the statistical results of the study report.
9 b2 J# A# U; O2 cOthers:
1.Provide programming consulting support throughout the department.
2.Provide biostatistical consulting within the company.
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2 h7 \5 P8 k) \( \7 ?工作地点 上海浦东新区 招聘人数 50人
学历要求 硕士 外语要求 英语
, e2 O+ O" X7 t# R; L) B专业要求 生物、统计、数学、应用数学以及计算机相关专业 简历语言 中文 英文
薪水 提供具竞争性之薪资(含车补及饭补) 补贴 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）
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职位要求 1.Master degree in Biostatistics, Statistics, Mathematics, Applied Mathematics, and Computer Programming or above requirement is preferable.
/ }. |* e+ X. `) x2.Knowledge of SAS programming skill or experience.
. i0 B4 _% P/ M9 D: C% \8 r! D3.Demonstrated excellent written and oral communications skills for interaction with a multidisciplinary project team, including statistics, clinical research, and data management.
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; |( @2 @5 O/ O- }  G/ l$ P( U% i2.招聘职位： Clinical Research Associate (临床监察员)
工作内容 1.To perform clinical monitoring activities of designated projects in accordance with the APEX SOPs.
( r/ p2 y+ r; d- q7 o: Q2.Accountable for detecting, analyzing and solving technical, procedural and/or motivational problems that may affect the progress of the project.
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: ?7 B& N3 \+ ]* }- V9 ^Pre-Study Stage
1.Participate in the identification and selection of potential investigators to ensure that the sites have adequate time and can fulfill their obligations to the study.
2.Assist or support those involved in regulatory and ethics committee/IRB submissions and in the generation of Financial Agreements according to standard and local country practices. Ensure that documents are collected in a timely manner to meet regulatory and ethics committee/IRB submission dates.
4 i  N! k9 i6 i9 G# {Study Initiation Stage
# M5 h4 a- o8 |( k* \3 U3.Initiate investigational sites to ensure that they have a thorough understanding of the clinical protocol and the requirements of the study, and that they can fulfill their obligations to conduct the study accurately.
0 t! |* \% [- n: I9 s4.Ensure the effective and timely co-ordination of the supply of clinical materials to the site.
In-Study Stage
' v- c" h& H8 s% S  v7 T  y+ W5.Perform site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site timely. Escalate Concerns or ongoing issues to the direct supervisor and the Project Manager.
$ q' ~; T* q* J- G' x% ]6.Provide ongoing training to the site personnel to ensure the quality and integrity of the data.
) f; H8 p' T, ~: u6 O2 U1 O7.Ensure that the principal investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities.
2 P8 r7 k* z# L3 T0 ]" OAdministrative Tasks
8.Prepare and submit visit reports and complete routine administrative tasks in a timely manner.
$ l* p  [: T! _* X9.Perform ongoing on site data management/collection to ensure that any issues are communicated to the site personnel timely. Maintain close contact with Data Management.
8 E# O* j% |. B5 X% H1 k+ q10.Maintain project tracking system on an ongoing basis to ensure that progress regarding the sites can be tracked and reported to the Project Manager as required.
11.Assist with the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures.
. Y% z- @% ^; v6 `8 U& H12.Attend staff meetings and training sessions as required to complete the Training Modules in a timely manner.
0 N( A$ [# ^8 `- J6 N+ k4 MStudy Files
13.Interact with investigators to obtain necessary documentation and information before, during and after the study. Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete and can be used as a source of reference.
% [3 k; e! Z8 A  P14.Assist with the audit of an investigational site or central files and liase with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP guidelines.
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+ _1 \, H/ C4 ^' N6 E% k4 Y7 Q" y工作地点 上海浦东新区 招聘人数 30人
学历要求 本科 外语要求 英语
! |- v) d$ i8 P$ H0 z( q专业要求 生命科学相关专业 简历语言 中文 英文
( ~& t+ j1 N. a( f" Z9 t) n薪水 提供具竞争性之薪资(含车补及饭补) 补贴 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）
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" j  H5 t  _. k) Z  z. o* A职位要求 1.A bachelor (or above) degree in a life science (preferably paramedical) field.
2.Relevant work experience (e.g., CRA, CR Assistant, Study Coordinator, data management).
7 Z* ^+ Y3 i3 ]7 \1 ~: Z, b6 @: k+ o9 N3.Good communication skill and proactive attitude.
+ R- }6 N, E' X8 o3 u4 G3 F4.Ability to take initiative and work independently.
- I( V  a  U$ L5 h. S5.Ability to speak and read the language(s) used locally in the country, plus a fluency in written and spoken English.
6.Willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of teamwork.
7.Ability to manage multiple and varied tasks, and prioritize workload with attention to details.
7 w4 V/ B% z- J- s8.Ability to travel – on both local and international trips.
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联系方式 负责人 黄小姐
0 \2 M- v; T/ C# Q; n4 z+ [: o+ E* o地址 上海市浦东新区张杨路620号中融恒瑞国际广场东塔22层2202-2206室
Email hr1@apex-cro.com
, s# A; U& S+ B, b电话 86-21-61609090-1301 传真 86-21-61609191-1301