Irina Dumitrache Email and Phone Number

- Lead Study builds consisting of both Initial Builds and Change Orders.- Provide scoping efforts for new assignments (initial system builds and change orders).- Ensure the correct functioning of clinical trial software with focus on patient safety and integrity of clinical study data, ensure all activities and deliverables comply with FDA regulations. - Verify that requirements are clear, testable, and consistent with the clinical trial protocol.- Develop validation plans according to a risk-based testing methodology.- Author and/or manage the completion of all validation related deliverables on each project.- Author, review, and execute test scripts. - Document defects and track resolution.

• Ensure the correct functioning of clinical trial software with focus on patient safety and integrity of clinical study data• Verify that requirements are clear, testable, and consistent with the clinical trial protocol• Ensure all activities and deliverables comply with FDA regulations• Develop validation plans according to a risk-based testing methodology• Author and/or manage the completion of all validation related deliverables on each project• Author and execute test scripts• Document defects and track resolution• Perform other related duties as required

QA & Testing: designing test scenarios, performing tests of web and mostly mobile applications, writing test reports, experience with bug tracking and reporting tools (Mantis), designing the user manual.Help desk: Lotus databases edition and duplication, Lotus servers administration, technical specifications translation from/to FR, RO, EN.

Coordinating customers portfolio: Customer Relationship Management (CRM), controlling deliverables (analysis, strategies, optimization plans) of the working group, coordinating the group’s actions, training the new members of the group, collaborating with the other working groups.

Building SEO Campaigns for French customers, Competition Studies, SEO Audits, Optimization Plans and recommendations for each customer, Creation of keywords-rich texts in French and English.

Translating documents (FR/RO, RO/FR).

Education