Responsible for the management of clinical trial activities including but not limited to monitoring, tracking, and managing the study budget.
Works with the project management to ensure that the data collection requirements are met and meet the clinical objectives and targets.
Work with clinical trial team to ensure that study timelines are met and are followed through the study protocol, CRF completion, and the principles of ICH-GCP guidelines.
Oversees the development of study data and/or clinical operations, including but not limited to, protocol, case report forms, informed consent form, case report forms, data management Plan, and other study specific
Selected to participate in the development of a new tool to improve the overall study performance and metrics. Provided support to the therapy department and the global project.
Proactively designs and implements process improvements to meet the needs of the Oncology group. Assist in the development of study protocols and communication plans.
Senior Project Manager
Western Carolina University
Manage the project management and responsible for the preparation of study budgets, data collection and tracking tools. Assist in the development of monitoring plans.
Create and maintain study database for monitoring visits, patient enrollment, and follow-up. Ensure data integrity and consistency in data collection.
Assist in the development of study specific documentation and data management plan. Manage the preparation of CRF design, database, and eCRF completion.
Ensure that all data capture activities are completed and in compliance with applicable regulations, SOPs, and monitoring requirements.
Manage study start-up activities including site visit, data reconciliation, and query resolution. Provide support for the project team.
Served as interim project Manager for the study team, including data collection, query resolution, and final report review.