Douglas Charles - Senior Manager Resume Simple
Highly motivated, goal-oriented, and results-driven professional with over 20 years of experience in the pharmaceutical industry. Strong background in the areas of pharmacy operations, and management.
  • management, project manager, documentation, leadership, manager, budgets, integration, supervision, efficient, quality, database, training, clients, data management, clinical
  • management, programming, ich, compliance, clinical trial, data management, statistics, testing, computer, database, validation, quality, fda, oncology, databases, medical, clinical
  • 2017-12-252017-12-25

    Senior Manager

    Concentric Healthcare Staffing

    • 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.
  • 2017-12-252017-12-25

    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.

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