Clinical operations: Responsible for the development, implementation, and documentation of quality assurance and metrics. Developed and implemented a system to improve the overall access and communication.
Manages the project team and the development of the project Plan, including the development of the project, budgets, and resources to support the performance of the clinical trial.
Assists in the development and maintenance of the project management Plan, including the planning, execution, and monitoring of the project metrics and timelines.
Supports the development and maintenance of project management systems, including the planning, execution, and evaluation of the project deliverables.
Supports the development and implementation of project plans and metrics to support the planning, execution, and maintenance of the clinical trial management system.
Provides leadership and coordination for the development and operations of the project budget. Monitors and tracks the progress of the project.
Clinical Data Manager
Lees McRae College
Support the development of clinical programming database validation and data quality control metrics. Manage and track data integrity and completeness.
Knowledge of ICH-GCP, FDA, and other regulatory requirements, data management, and QA/QC databases for clinical data reporting.
Create and maintain database for clinical research studies, integration of data and databases, and reporting of adverse events to the FDA.
Provided support to clinical research associates and data managers in the development of protocols, CRFs, and database validation for Oncology and clinical trials.
Ensuring compliance with study requirements, including but not limited to: protocol, CRF completion, SAE reconciliation, data query resolution, and query resolution.
Completes data entry and validation of clinical databases, including but not limited to: Electronic data capture (EDC), QA/QC, and testing.