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Job Id
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3082024A
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Title
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EDC Analyst
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Job Type
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Permanent
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Duration
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City
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Hyderabad
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State
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Telangana
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Zip
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500081
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Job Description
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Job Overview: The EDC Analyst plays a critical role in managing clinical trial data by overseeing Electronic Data Capture (EDC) systems and providing analytical support. Ideal candidates will have a background as a Clinical Research Associate and experience in supporting EDC and Clinical Trial Data Applications/Software tools.
This role requires collaboration with cross-functional teams to maintain EDC platforms, optimize data collection processes, and contribute to the overall success of clinical trials.
Key Responsibilities: - Manage and support the design and development of EDC databases.
- Lead the analysis, development, and enhancement of functional and technical processes to improve workflow.
- Collaborate with stakeholders using an Agile approach to enhance system functionality and efficiency.
- Ensure the accuracy and completeness of clinical trial data within EDC systems.
- Develop and maintain data validation specifications and edit check programs.
- Collaborate with clinical and data management teams to resolve data discrepancies.
- Conduct user acceptance testing (UAT) for EDC system enhancements.
- Contribute to process improvement initiatives for data collection and management.
- Ensure compliance with regulatory guidelines and industry standards.
- Participate in audits and inspections related to EDC systems and data management.
- Stay updated on technological advancements in EDC and data management.
- Ensure all documentation complies with SOPs and supports UAT and other operational needs.
- Coordinate RFPs with stakeholders for vendor and application selection, ensuring quality standards are met.
Required Qualifications: - Bachelor’s degree in Life Sciences or a related field.
- Minimum of 2 years of experience in clinical data management or a related role.
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle InForm).
- Knowledge of regulatory requirements for clinical trials.
- Excellent problem-solving and analytical skills.
- Ability to work effectively in a team environment.
- Strong communication and interpersonal skills.
- Detail-oriented approach with a commitment to data quality.
- Familiarity with best practices in electronic data capture.
- Experience in user acceptance testing (UAT) for EDC systems.
- Understanding of data integration and migration processes.
- Certification in clinical data management is a plus.
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Qualification
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Certification/Licensure
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Experience
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2-5 Years
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Job Category
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CRA
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Posted On
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8/30/2024
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Expires On
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9/30/2024
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