Nosimanana Jacquinot Mangolo

Responsibilities:

• Performed all Data Management activities from CRF design to database lock.
• Managed study timelines, budgets, metrics, and data review plans.
• Developed Data Management plan, Data transfer agreements, CRF Completion guidelines, and other DM-specific documents.
• Ensured that all clinical data management activities are compliant with DMP, SOPs, CFR 21 Part 11, and ICH GCP.
• Developed/Generated SAS programs according to clinical project needs.
• Interacted with statistician back and forth and discussed the various updates in the specification.
• Performed data-management training for the research staff, including preparing training materials.
• Assisted with the coordination of audits conducted by consultants.
• Performed data-management training for the research staff, including preparing training materials.
• Assisted with the coordination of audits conducted by consultants.

Responsibilities :

• Developed Data Management plan, Data transfer agreements, CRF Completion guidelines, and other DM specific documents.
• Coordinated with the CROs, and external vendors.
• Responsible for the design and development of Case Report Forms (CRF) in collaboration with CRAs or Clinical Project/Program Managers.
• Ensured project schedule is developed and agreed upon for each defined project.
• Created and maintained data management plans, Data Review guidelines, and other study-specific work instructions or guidelines for multiple projects.
• Coordinated and set up all sites at the study start-up.
• Mentored junior level staff on all associated tasks within a study.

Responsibilities:

• Conducted all data management tasks for data review, writing, and clearing data clarifications.
• Created and maintained data management plans, Data Review guidelines, and other study-specific work instructions or guidelines for multiple projects.
• Determined what accounts were to billed to patient according the patients plan benefit design
• Collaborated with internal and external teams for database transfers.
• Provided the necessary data for Safety Reviews, DSMBs, and Safety Committees
• Mentored junior-level staff on all associated tasks within a study.

• Performed data review, validation, query development, and resolution.
• Conducted User Acceptance Testing of data entry screens to reflect protocol requirements, providing a streamlined, timely, and efficient database roll out.
• Participated in different tasks in collaboration with the Clinical Project Manager (CPM)
• Performed Data monitoring and contact with the sites to ensure the data locks within the allocated time.
• Supported Project officers and data managers in Users management.

• Designed and validated clinical databases including designing or testing logic checks.
• Generated data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems.
• Reviewed and approved recommended changes; performed final data entry of changes.
• Worked in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection.

• Performed all Data Management activities from CRF design to database lock.
• Developed Data Management plan, Data transfer agreements, CRF Completion guidelines, and other DM-specific documents.
• Worked as a primary person from CDM in meetings with Clinical, Safety, and Biostatisticians.
• Trained team members in best practices for data handling, improving overall productivity and data integrity.
• Oversaw all data management activities, including discrepancy management, SAE reconciliation, cleaning, and coding.

• Performed registry and case assignment tasks as needed.
• Performed Data entry of case reports into safety databases ( SafetyEasy and Argus Safety Database).
• Requested follow-up and performed query management.
• Performed the data coding using WhoDRUG and MedDRA dictionaries.
• Case reconciliation- coordinated the activities with Data Management personnel.

• Designed and validated clinical databases including designing or testing logic checks.
• Generated data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems.
• Interacted with external project team members to help with data collection and clean-up efforts.
• Performed data-management training for the research staff, including preparing training materials.

• Developed/built, reviewed, and maintained a clinical database and supporting specifications documentation.
• Performed data validation checks, raised data queries and reconciled data from external sources.
• Prepared study datasets for statistical analysis.
• Performed descriptive statistical analysis.

• Conducted literature reviews and determined the accuracy and validity of sources.
• Developed data analysis plan for the research study.
• Conducted appropriate statistical analysis, interpreted, and reported results of both primary and secondary data while observing epidemiological standards of practice.
• Reported results of the statistical analyses in the form of graphs, charts, and tables using superb documentation practices to ensure data integrity and traceability.

• Coordinated several phases 3 clinical research studies in the field of endocrinology.
• Managed source documents and logging patient visit data into electronic data centers.
• Recorded all adverse events and reporting them according to study and IRB requirements.