A highly motivated, detail-oriented, and results-driven professional with over 15 years of experience in the pharmaceutical industry. Strong background in the areas of pharmacy and medical device industries.
management, reconciliation, quality, documentation, data management
Provided support to the project team in the planning and execution of staffing. Developed and maintained effective communication with the client.
Assists in the development of study related documents and tools. Prepares and maintains project specific documentation. Develops and maintains data management plan.
Managed data management activities for multiple projects. Reviewed and approved study protocols. Provided support to clinical research associates.
Assisted in the development of study documents and data listings. Reviewed and approved protocols. Developed and implemented processes.
Supported the development of project plans, data management Plan, and study specific tools. This includes, but not limited to, the creation of the CRF design, eCRF design, edit check, and data validation
Developed and implemented processes and procedures to ensure consistency and efficiency. Built and maintained project timelines and deliverables. Provided technical support to enable the development of study plans.
Senior Clinical Data Manager
Conducted quality control and data management reconciliation for the trial Master file. Reviewed and approved all study related documents.
Reviewed and approved study documentation for completeness and accuracy. Prepared and submitted regulatory documents for submission to the IRB.
Supported the development and implementation of clinical databases and data management systems. Provided support to the project team and the project manager.
Reviewed and approved study specific documents (e., CRFs, ICFs, CRFs, etc.,) for completeness and accuracy.
Supported the development of study specific documents (e.K.g. And data collection forms). Performed data review and analysis.
Developed and maintained project timelines and milestones to ensure timely completion of deliverables and timelines. Coordinated with the project team to ensure that study milestones were met.