Sample interview questions: Have you worked with any electronic trial master file (eTMF) systems?
Sample answer:
- Experience with eTMF systems:
- DocuSign: Managed eTMF for multiple clinical trials, ensuring compliance with regulatory requirements.
- Veeva Vault: Implemented and configured eTMF system for a global pharmaceutical company, streamlining document management and collaboration across multiple sites.
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Medidata Rave: Utilized eTMF system to capture, manage and track electronic documents throughout the clinical trial process.
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Strong understanding of regulatory requirements:
- Proficient in ICH GCP and FDA 21 CFR Part 11 regulations.
- Expertise in developing and implementing eTMF policies and procedures to ensure compliance.
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Experience working with regulatory authorities, addressing queries and ensuring timely submission of required documentation.
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Proficient in data management and analysis:
- Skilled in using statistical software packages such as SAS and SPSS to analyze clinical trial data.
- Experience in developing and executing data analysis plans to evaluate the safet… Read full answer
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