Rick Michael Walls
Senior Clinical Trial Manager @Worldwide Clinical Trials
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WORK HISTORY
Senior Clinical Trial Manager @Worldwide Clinical Trials
Dallas, TX, US
Therapeutic Areas: Oncology, Rare Disease• Collaborate with Project Management to set site management targets/monitoring strategy and ensure compliance with project goals and Worldwide processes• Provide leadership and direction to clinical site management team members from study start through to closure• Serve as Site Management (SM) primary point of contact and representative for clinical monitoring and site activities within the project• Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities• Customize study-specific SM Quality Management Documents, e.g, the Clinical Monitoring Plans (CMP)• Oversee compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters• Review protocol deviations and visit action items to ensure that activities are conducted according to the CMP.• Provide CRAs training all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed• Drive efforts to improve the quality of site data and address any identified needs with action plans. Review data metrics to ensure data integrity and quality• Track/measure SM deliverables to identify trends. Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed• Oversee TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on target and TMF is inspection ready• Formulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed• Review/finalize trip reports according to Worldwide SOPs and expectations
EDUCATION
The University of Texas at San Antonio
BS, Biology
University of Texas
Bachelor of Science, Biology
SKILLS
ABOUT RICK MICHAEL WALLS
Strategic, results-driven Sr. Clinical Trial Manager with over 20 years of experience in the pharmaceutical and medical device industry, phases I-IV. Experience covers a wide range of business and scientific disciplines, including but not limited to Oncology (Immuno-Oncology), Infectious Disease, and Cardiovascular disease. Successful at all aspects of site management from start up activities to follow up and close out to final deliverable.
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