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 Clinical Study Manager

Details
Country: USA
Location: Missouri-St. Louis St. Louis
Total applied: 48
Job Category:Biotech/R&D/Science
Location:US-MO-St. Louis
Status:Full Time, Employee
Occupations:General/Other: R&D/Science
Career Level:Manager (Manager/Supervisor of Staff)
Clinical Study Manager

Position Description:

Clinical Study Managers Needed!KV Pharmaceutical seeks Clinical Study Managers. The successful candidates will direct and/or coordinate clinical research programs designed to support the Company’s effort to obtain approved New Drug applications and Abbreviated New Drug Applications for various therapeutic entities. You will manage one or more clinical research project teams which may include internal personnel or external vendors. The incumbent will be responsible for financial and operational performance of assigned projects to ensure that project/program milestones and objectives are met. This position supports the development of the project/program scope of work, project costs, timelines, metrics and deliverables. The successful candidate will have a bachelor’s degree, preferably in a scientific discipline. Minimum four years of clinical research experience and two years of clinical study management experience in a pharmaceutical/biotechnology company, CRO, or clinical trials research environment. Minimum of one year supervisory experience required, two years preferred. You must have the ability to travel as needed (estimated at 25% to 30%). If you have detailed knowledge of FDA/GCP/ICH clinical requirements for clinical trial conduct, the ability to exercise independent judgment and creativity in developing methods, techniques and evaluation criteria for obtaining results this may be the position for you. We are seeking a self-motivated individual with the ability to be effective with minimum supervision. You must have demonstrated success in collaboration with others, have the ability to use independent thought, judgment and creativity to formulate and implement effective solutions to complex problems. Excellent communication skills (both written and oral) and ability to interact with many departments,KV Pharmaceutical Company, a dynamically growing organization, (www.kvph.com) has reported its 12th consecutive year of record revenues in Fiscal 2007, reporting net sales of over $440 million. KV is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technologically distinguished products through Ther-Rx Corporation, our branded wholly-owned subsidiary and ETHEX Corporation, our generic/non-branded wholly-owned subsidiary. With more than 60 years in business, KV applies its 15 unique patent protected and proprietary drug delivery technologies to both the brand and generic/non-branded subsidiaries. Based in St. Louis, Missouri, St. Louis is One of Forbes’ “200 Best Metropolitan Areas” in America in 2006. St. Louis was also named the second most affordable large metropolitan area in the country by the National Association of Home Builders in 2005. St. Louis offers a world-class medical community with over 50 general practice, teaching and research hospitals including Washington University and St. Louis University. St. Louis is also rich in education with more than a dozen nationally-recognized four-year universities.KV Pharmaceutical (NYSE: KVa/KVb) provides a comprehensive benefits package including a 401(k) and profit-sharing, health, vision, and dental. We offer competitive salaries and stock options for many positions which have proven to be lucrative to many long-term KV employees. EOE M/F/D/V

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