Develop and coordinate clinical research programs designed to support the KV effort to obtain approved New Drug applications and Abbreviated New Drug Applications for various therapeutic entities in sustained release dosage forms and conventional dosage forms. Provide clinical research support for company marketing/sales efforts and other corporate projects as required. Develop and implement Phase I, II, III and IV clinical protocols/studies in a variety of therapeutic areas. Provide required input for IND, NDA, ANDA and routine FDA submissions. Coordinate all clinical research activities within KV Pharmaceutical Company. Develop and maintain clinical research SOPs. Prepare and manage departmental budget.
Direct, supervise and develop Project Managers and/or Project Directors, providing scientific support and operational advice as and when needed. To take responsibility for the commercial and technical success of all projects under the direction of the Sr. Director. To ensure Customer satisfaction for all projects responsible. To work with Business Development to ensure the development and growth of new business. Develop Training programs to maximize the potential of all project managers/directors in the business unit. Continuously review project tracking tools to ensure they are providing adequate information for the Oncology Business to understand the status of projects under the direction of the Senior Project Director.
Overall responsibility for project management, monitoring and administration of all clinical trials conducted by Texas Biotechnology Corporation. Duties include: supervision of all operational aspects of clinical trial programs, all planning and administration functions within the Clinical Development and Regulatory Affairs Division including financial management, resource management, project planning and general administration. Supervised a team of 2 project managers, 6 clinical research associates, 1 administrative manager and 2 administrative assistants. The team had responsibility for 3 drugs in Phase I through Phase III clinical development. Also responsible for development, tracking and adherence to Clinical Development and Regulatory Affairs Division budget.
Responsible for all aspects of the management of single and multicenter clinical research studies. Responsibilities included: sponsor liaison, protocol development, case report form development, study planning, timeline generation and maintenance, site recruitment, investigator meeting planning, oversight of study progress including contractual and fiscal obligations or research studies, IND preparation and study report generation. Also responsible for the management of teams of less senior Project Managers, Clinical Research Associates, Data Managers, Medical Writers and Clerical personnel. Responsible for direct line supervision of four project manager direct reports and five clerical staff direct reports. During my tenure at Pharmaco LSR, I managed projects encompassing 24 different clinical studies in three different therapeutic areas with combined overall budgets of approximately $ 21 million
Responsible for all aspects of monitoring 7 sites encompassing two protocols to evaluate a novel antidepressant. Assigned to team responsible for preparation and submission of an NDA for a new tricyclic antidepressant. Wrote three protocols and one final study report.
Responsible for the management of three domestic and one foreign multicenter clinical trial involving 70 domestic and 10 foreign investigators and a total of 2800 patients. Responsibilities included assisting in the preparation of protocols and case report forms, preparation of weekly and monthly progress reports, investigator recruitment, timeline preparation and maintenance, supervision and training of CRAs, project expense accounting, negotiation and management of investigator budgets and liaison with investigators, project sponsor and project vendors.
Responsible for all aspects of monitoring 8 sites encompassing two protocols. Monitoring duties included monthly site visits, grant disbursement, monthly reporting, adverse event monitoring and drug accountability. Conducted investigator recruitment and qualification, study initiation, monthly monitoring and study close-out. Assisted in protocol and case report form development and NDA compilation and submission.
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