Job Description
The Clinical Data Analyst II (CDA II) shall be responsible for data processing activities on a project and shall ensure quality standards according to SOPs and ICH-GCP. Areas of responsibility shall include; data cleaning and query generation, support in data entry and CRF tracking, medical coding, SAE reconciliation and quality support on projects The CDA shall support on project meetings and telephone conferences where required. The CDA shall support the Project Lead on a project on tasks as needed.
• Review the respective study protocol/CRF
• Perform data cleaning (manually or automatically) and generate DCFs.
• Perform medical coding
• Perform SAE reconciliation
• Development of project-specific status reports
• Support data entry for UAT and production
• Track and review CRFs
• Setup and review of study documents and ensure proper documentation on projects
• DM QC as assigned
• Review of study databases including data-entry screens
• Input in development of SOPs, improvement initiatives and processes
The Clinical Data Analyst II (CDA II) shall be responsible for data processing activities on a project and shall ensure quality standards according to SOPs and ICH-GCP. Areas of responsibility shall include; data cleaning and query generation, support in data entry and CRF tracking, medical coding, SAE reconciliation and quality support on projects The CDA shall support on project meetings and telephone conferences where required. The CDA shall support the Project Lead on a project on tasks as needed.
• Review the respective study protocol/CRF
• Perform data cleaning (manually or automatically) and generate DCFs.
• Perform medical coding
• Perform SAE reconciliation
• Development of project-specific status reports
• Support data entry for UAT and production
• Track and review CRFs
• Setup and review of study documents and ensure proper documentation on projects
• DM QC as assigned
• Review of study databases including data-entry screens
• Input in development of SOPs, improvement initiatives and processes
Candidate Profile
Should posses atleast 4yrs of experience in data management.
• Ability to work with cross-functional groups
• Ability to understand complex organizational relationships
• Willingness to work overtime
• Detail-oriented with ability to work creatively and flexible in a fast-paced environment
• Good English knowledge
• Good knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG) will be added advantage
• Basic knowledge of PC or Unix SAS will be added advantage
• Demonstrate a sound awareness of all relevant regulations, including GCP
Additional Information:Should posses atleast 4yrs of experience in data management.
• Ability to work with cross-functional groups
• Ability to understand complex organizational relationships
• Willingness to work overtime
• Detail-oriented with ability to work creatively and flexible in a fast-paced environment
• Good English knowledge
• Good knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG) will be added advantage
• Basic knowledge of PC or Unix SAS will be added advantage
• Demonstrate a sound awareness of all relevant regulations, including GCP
Experience: 4 years
Location: Andhra Pradesh - Hyderabad
Functional Area: CR
Requisition: pare-10033140
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 15th June, 2014
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