Clinical Research Analyst
Job Code: 002
Job Location: Hyderabad
Job Description: • Develop Case Report Form (CRF), electronic and/or paper.
• Performing Data entry for paper CRF.
• Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports)
• Participates in EDC database (DB) specification process
• Execution of test scripts and maintaining logs for User Acceptance Testing (UAT)
• Reconcile electronic data transfers from vendor to Sponsor.
• Provide Clinical data management support to Clinical Operations team and Biostatistics Team
• Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
• Develop Data Management Plan (DMP), maintains DMP throughout Lifecycle of study project and ensure DMP is followed according to study Design and requirements.
• Provides input and reviews clinical trial database design including User Acceptance Testing (UAT).
• Lead EDC database (DB) specification process.
• Reconcile electronic data transfers from vendor to Sponsor.
• Perform training on data management software and practices or trial specific topics as required.
• Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks
• Performing Data entry for paper CRF.
• Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports)
• Participates in EDC database (DB) specification process
• Execution of test scripts and maintaining logs for User Acceptance Testing (UAT)
• Reconcile electronic data transfers from vendor to Sponsor.
• Provide Clinical data management support to Clinical Operations team and Biostatistics Team
• Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
• Develop Data Management Plan (DMP), maintains DMP throughout Lifecycle of study project and ensure DMP is followed according to study Design and requirements.
• Provides input and reviews clinical trial database design including User Acceptance Testing (UAT).
• Lead EDC database (DB) specification process.
• Reconcile electronic data transfers from vendor to Sponsor.
• Perform training on data management software and practices or trial specific topics as required.
• Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks
Functional Area: Pharmaceuticals
Functional Role: Quality Assurance/Control Manager
Candidate Requirement
1)Should have good experience in develop Case Report Form (CRF), electronic and/or paper.
2)Should able to Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigation site, to ensure high quality and timely database locks..
2)Should able to Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigation site, to ensure high quality and timely database locks..
Experience: 2 - 3 years
Qualification: B.PHARMA(Pharmaceutical Marketing)
Preferred Resume Format: MS-Word
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