Diana Schab Email & Phone Number

Montreal, Quebec, Canada

Support the initiation and coordination of a variety of projects with tasks including database management, entering data of all kinds (medical records, questionnaires, administrative data, laboratory data), controlling data entry quality, clinical follow-ups of research participants according to the study protocol, ensuring overall compliance with study protocols, and occasionallyapproaching families to participate in clinical research.

Montreal, Quebec, Canada

• Increased study/site efficiency and compliance by analyzing data trends and assessing study performance metrics. • Performed central data review and validation of all studies.• Led and delegated tasks to ensure timely completion of project activities within project timelines and quality standards.o Established and developed strong customer relationships throughout the life of projects.• Communicated frequently and responsively with customers and clinical partners maintaining proactive contact.• Coordinated project requirements with clinical partners and third-party vendors.• Performed project forecasting of study milestones and completion dates based on historical data.• Organized and facilitated risk management meetings for clinical studies, addressing potential issues proactively.• Implemented and set up a comprehensive Clinical Trial Management System (CTMS) for future studies.

Montreal, Canada Area

• Managed the preparation and organization of study documents and reports; FDA 1572, CVs, medical license, IRB submissions/approvals.• Prepared informed consent forms, and reviewed translations.• Coordinated and organized investigator meetings, including logistics and agendas.• Facilitated communication between study sites and internal teams to address and resolve any study-related issues.• Provided administrative support for study teams, including scheduling meetings and maintaining accurate records.• Assisted with managing project budgets, identifying out-of-scope work.• Compiled and managed EDC reports, ensuring accurate and timely data collection and reporting.• Monitored and tracked enrollment numbers, addressing enrollment issues to facilitate uninterrupted study progression.• Assisted in the development and maintenance of risk management tracking systems to enhance project oversight.

Montreal, Canada Area

• Managed commercial packaging master files in compliance with government standards and customer requirements.• Coordinated and provided adequate documentation for commercial plants’ production needs.• Produced variances and change controls, assessed requests for revisions and holdbacks, and recorded product specifics.• Authored and maintained packaging specifications for all products from the internal plant or external vendors.

Montreal, Canada Area

• Coordinated and provided adequate documentation for commercial plants’ production needs.• Wrote variances and change controls, assessed requests for revisions and holdbacks, and recorded product specifics.• Wrote and maintained packaging specifications for all products from the internal plant or from external vendors.

Laval, Quebec

• Managed essential study documentation and filed in electronic system.• Adapted Patient Informed Consent Forms (ICFs) to company guidelines, reviewed site specific ICFs and verified translations.• Generated monthly reports, effectively supporting the development process through computerized systems.• Processed reportable and non-reportable CIOMS for internal review and signature.• Managed receipt of Case Report Forms, tracked, and forwarded to data management.• Archived closed-out studies; reviewed all documentation related to the Trial Master File.

St-Laurent, Qc

• Prepared and distributed relevant documents; IRB/EC approvals, regulatory forms, 1572s, financial disclosures.• Managed multiple tasks during study start-up process.• Tracked and filed essential study documents in electronic tracking and filing system.• Completed requests for investigator payments.

Montreal, Quebec, Canada

• Coordinated and managed clinical trial activities according to protocols and regulatory requirements.• Maintained and updated Trial Master Files and other trial-related documentation.• Participated in internal team meetings, provided updates and collaborated on trial activities and issues.• Coordinated site supplies and assisted in the preparation of investigator meetings.

St-Laurent, Qc

• Coordinated and managed clinical trial activities according to protocols and regulatory requirements.• Maintained and updated Trial Master Files and other trial-related documentation.• Participated in internal team meetings, provided updates and collaborated on trial activities and issues.• Coordinated site supplies and assisted in the preparation of investigator meetings.

Bachelor Of Arts (B.A.), Linguistics

Activities and Societies: Polish Student Association

Aec, Computer Programming

Master Of Business Administration - Mba, Pharmaceutical Marketing And Management