Desired Profile Responsible for programming of edit checks based on the approved edit specifications document.
Create, implement and execute validation procedures to build and maintain discrepancy database set-up for paper based and/or web based (RDC) clinical data management systems (CDMS) in standard format.
Create and review (electronic) Case Report Forms per Protocol and Annotated Case Report Forms
Write, review and maintain eCRF completion guidelines, data management plan(DMP), Data Validation Plan (DVP, e.g.
Perform or assist in all aspects of DM process as related to processing QC /review/ UAT and subsequent updation of the findings of the data.
Write and review DM SOPs in accordance with GCO and ICH guidelines, develop associated training and competency testing
Clean data for study close out and perform all database lock procedures
Work in conjuction with Clinical Operations, Clinical Research, and other operations to ensure, accurate, efficient and complete data collection
Contact Metalink and/or Oracle Clinical User Group for validation related issues. As required, based on the response shall suggest IT team about bug fixation / patch updation.
Solve operational problems related with database (front end) and CDM processes.
To perform all related activities of data management like data entry, data coding, data reconciliation and SAE.
Solve operational problems related with database (front end) and CDM processes.
To assist manager in holding QA audits and providing Corrective and Preventive action plan.
Must have experience in CDM with more than 3 years
Well versed with Oracle Clinical/ Remote Data Capture (OC/RDC) specially programming, SQL, PL SQL.
Must have experience in CDM with more than 3 years
Experience 3-4 years
Age 22 - 40Years
Industry Type Pharmaceutical
Functional Area Clinical Research
Education B.Com/B.Sc/B.Pharma etc & Diploma/degrees in Information Technology(IT)/Profesional qualification etc
Email corporate@panaceabiotec.com, rohitkumar1@panaceabiotec.com
Website http://www.panaceabiotec.com/
Job Posted June 19, 2014
Create, implement and execute validation procedures to build and maintain discrepancy database set-up for paper based and/or web based (RDC) clinical data management systems (CDMS) in standard format.
Create and review (electronic) Case Report Forms per Protocol and Annotated Case Report Forms
Write, review and maintain eCRF completion guidelines, data management plan(DMP), Data Validation Plan (DVP, e.g.
Perform or assist in all aspects of DM process as related to processing QC /review/ UAT and subsequent updation of the findings of the data.
Write and review DM SOPs in accordance with GCO and ICH guidelines, develop associated training and competency testing
Clean data for study close out and perform all database lock procedures
Work in conjuction with Clinical Operations, Clinical Research, and other operations to ensure, accurate, efficient and complete data collection
Contact Metalink and/or Oracle Clinical User Group for validation related issues. As required, based on the response shall suggest IT team about bug fixation / patch updation.
Solve operational problems related with database (front end) and CDM processes.
To perform all related activities of data management like data entry, data coding, data reconciliation and SAE.
Solve operational problems related with database (front end) and CDM processes.
To assist manager in holding QA audits and providing Corrective and Preventive action plan.
Must have experience in CDM with more than 3 years
Well versed with Oracle Clinical/ Remote Data Capture (OC/RDC) specially programming, SQL, PL SQL.
Must have experience in CDM with more than 3 years
Experience 3-4 years
Age 22 - 40Years
Industry Type Pharmaceutical
Functional Area Clinical Research
Education B.Com/B.Sc/B.Pharma etc & Diploma/degrees in Information Technology(IT)/Profesional qualification etc
Email corporate@panaceabiotec.com, rohitkumar1@panaceabiotec.com
Website http://www.panaceabiotec.com/
Job Posted June 19, 2014
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