Qualification & Experience: Bachelor’s degree preferably in field of life science/computer science with at least a diploma in computer applications with 5 to 8 years of data management experience in the health, pharmaceutical or biotechnology industry, out of which 2-3 years of experience as DM Lead or Manager
Skills:
* Knowledge of GCDM Practices
* Proficient in Microsoft Office applications, Internet, software, E-mail
* Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture (EDC) systems
* Experience with SAS (Base, Stats, Macro, etc.)
* Experience with CDISC SDTM/CDASH
* Knowledge of GCDM Practices
* Proficient in Microsoft Office applications, Internet, software, E-mail
* Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture (EDC) systems
* Experience with SAS (Base, Stats, Macro, etc.)
* Experience with CDISC SDTM/CDASH
Job Description
* Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms
* Develop, review, and maintain a clinical database
* Develop, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing)
* Develop data transfer agreements and specifications with various vendors
* Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation
* Perform all aspects of DM process as related to processing and QC of the data
* Clean data for study close out and perform all database lock procedures
* Monitor study status (e.g. enrolment, CRFs, etc.) and provide status reports to the team
* Use standard conventions, tools, references and process in support of the coding of medical terms
* Ensures all DM procedures executed with a high attention to detail, accuracy and timelines
* Represent the DM function on project teams
* Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing
* Maintain CRFs and database standards
Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection
* Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms
* Develop, review, and maintain a clinical database
* Develop, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing)
* Develop data transfer agreements and specifications with various vendors
* Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation
* Perform all aspects of DM process as related to processing and QC of the data
* Clean data for study close out and perform all database lock procedures
* Monitor study status (e.g. enrolment, CRFs, etc.) and provide status reports to the team
* Use standard conventions, tools, references and process in support of the coding of medical terms
* Ensures all DM procedures executed with a high attention to detail, accuracy and timelines
* Represent the DM function on project teams
* Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing
* Maintain CRFs and database standards
Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection
Age Limit (Type of position): 45 years
Date of publication of shortlisted candidates: 15th April, 2014
Date of conduct of Interview: 25th April, 2014
Date of publication of result: 30th April, 2014
Last date for joining: 15th May, 2014
Date of conduct of Interview: 25th April, 2014
Date of publication of result: 30th April, 2014
Last date for joining: 15th May, 2014
Candidates interested to apply for the above position are required to submit their CV to pbc@thsti.res.in
CLICK HERE FOR MORE INFO
Subscribe to us
100% Free.
Get It
close
No comments:
Post a Comment