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Clinical Data Associate / Clinical data management

3.00 to 8.00 Years   Mumbai City   24 Sep, 2020
Idexcel Technologies Private Limited
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

Currently we are hiring for Clinical Data Associate roleClinical data management experience- 3 to 5 yrs of core Clinical data management. Have worked mainly on the Conduct phase of the trail- tasks can be query management, listings review and minimal experience of Start up and closeout activities. Database experience- Medidata Rave, inform. Ability to work in a team environment and independently as needed Ability to work productively with support and minimal supervisionBasic Purpose and objective:

  • To perform all aspects of the data cleaning process in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs)/ Working Practice Documents (WPDs).
  • Duties and Responsibilities (according to relevant guidelines, laws and SOPs) Support the set up of study activities such as CRF design, database design, including testing of data entry screens, and DVM creation, as required.
  • This includes taking responsibility for accurately reporting and documenting discrepancies to the Lead Clinical Data Manager (Lead CDM).
  • To fulfill all data management cleaning activities, in accordance with the Data Validation Manual (DVM) and/or sponsor documentation.
  • May perform dictionary coding of items specified in the DVM.
  • To perform all Quality Control (QC) processes as defined in the DVM.
  • To ensure that all work conducted is completed to the acceptable quality in accordance with SOPs/WPDs and DVM.
  • To ensure Case Report Forms (CRFs) are logically filed and are easily located by appropriate team members.
  • To ensure all required documentation, as defined in the SOPs/WPDs and DVM, is created and filed correctly.
  • To provide accurate status information of all individual work conducted daily and, at the request of the CDM management, the overall study status. May provide training, mentoring and work direction to junior staff.
, Education:UG -Graduation Not Required

Keyskills :
good clinical practicedata cleaningmedidata ravecrfcase report formsclinical datadata managementquality controlstandard operating procedures

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