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辉瑞(中国)研究开发有限公司

  • 公司行业:科研机构
  • 公司规模:100-200人
  • 公司性质:乡镇企业
  • 成立时间:2020-10-22

招聘【Central Monitor I, Risk Based Monitoring(J17947),3人】

招聘专业: 招聘人数: 3人
工作类型: 兼职 月  薪: 4000-5000元
要求性别: 不限 年龄要求: 20 --30岁
学历要求: 硕士 工作地区: 湖北省武汉市
工作经验: 2-3年 职位类别:
外语要求: 不限 外语等级: 一般
政治面貌: 群众 户口要求:
发布日期: 2021/2/9 有效期限: 2021/4/10
相关福利
具体要求

工作职责:

ROLE  RESPONSIBILITIES  

General:

? Implement  global  strategies,  initiatives,  processes,  and  standards  to  ensure  consistent,  efficient,  and  quality  processes  to  meet  quality,  timelines  and  deliverables.

? Provide  technical  expertise  to  set  up  and  test  study  level  Risk-based  Monitoring  system

? Review  study  level  system  outputs  to  process  for  the  signal  and  action  management

? Execute  communication  plans  &  methods  to  ensure  customer  satisfaction  and  enable  improvements  to  be  implemented  during  the  course  of  a  study.  

? Provide  technical  support  to  resolve  conflicts,  influence  and  communicate  with  key  stakeholders  and  customers.

System  setup  Functions:

? Set  up  and  test  RBM  system  at  study  level  to  ensure  system  quality.

? Define  key  risk  indicators  (KRIs)  in  study  system,  and  ensure  consistency  between  the  standard  level  and  the  study  level.

? Ensure  RBM  system  align  with  the  protocol  and  adhere  to  ICH  GCP,  SOPs,  corporate  standards  and  regulatory  requirements.

Data  review  Functions:

? Provide  technical  support  to  define  the  issue  resolution  for  the  reviewing  findings  as  signal  and  action.  

? Implement  and  maintain  Quality  Control  related  documentations  for  RBM  related  activities  to  ensure  data  completeness  and  accuracy.

? Perform  central  monitoring  activities  including  review  system  outputs,  propose  suggestion  for  signal  and  action  management,  and  follow  up  with  study  team  for  the  action  resolution.

? Work  with  Clinical  Data  Scientist  (CDMM)  to  ensure  all  signal  and  actions  are  properly  mitigated  and  RBM  systems  properly  released.      

任职资格:

 

BASIC  QUALIFICATIONS:  

? Bachelor’s  degree  or  above  of  equivalent  experience  in  a  scientific  or  business  related  discipline  required.

? Technical  expertise  in  supporting  clinical  trials  database  development,  data  management,  site  monitoring,  etc.

? Familiar  with  the  processes  associated  with  clinical  study  management,  data  management,  and  regulatory  operations.

? Technical  capabilities,  effective  verbal  and  written  communication  skills  in  relating  to  colleagues  and  associates  both  inside  and  outside  the  organization.

? Works  independently,  receives  instruction  primarily  on  unusual  situations

? Ability  to  organize  tasks,  time  and  priorities;  ability  to  multi-task

? Ability  to  communicate  with  internal  &  external  stakeholders,  locally  and  globally

? Minimum  1  year  experience  related  to  clinical  trial  (CRA,  DM,  Programmer,  etc.)

PREFERRED  QUALIFICATIONS:

? Working  knowledge  of  clinical  development  process,  understanding  concepts  of  Phase  I-IV  and  principles  of  study  design

? Previous  experience  within  a  data  management  role,  understanding  key  processes  and  principles  associated  with  role  including  CRF  design,  database  set-up,  edit  check  specification,  DMPs  and  data  cleaning  activities

? Knowledge  of  clinical  trial  database  and  its  applications  

? Knowledge  of  Windows  Environment  and  its  applications  (Word,  Excel,  PowerPoint,  Project,  etc.)

? Experience  in  Oracle,  PL/SQL,  SAS,  Java,  relational  database  design  and  database  programming  skills.

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