Trial Manager needed in Yardley, PA! Must have Global experience!

Description Tibotec Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Manager, Global Clinical Research position located in Yardley, PA. Tibotec Inc. discovers and develops anti-retrovirals and anti-infectives. The company currently has anti-retrovirals in clinical development in both the non-nucleoside reverse transcriptase inhibitor and protease inhibitor classes. The company also has drugs in development for TB and HCV. The company's marketed products include; PREZISTA(tm) (darunavir 300mg), a protease inhibitor for the treatment of HIV/AIDS and TIBOZOLE(tm) (miconazole nitrate 10 mg), a muco-adhesive tablet containing miconazole for once daily topical treatment of oro-pharyngeal candidiasis, the most common opportunistic infection in people with HIV/AIDS in Africa. As leader of the Clinical Trial Team, you will: Manage clinical trial activities in line with the (CDP) Clinical Development Plan (content, planning and budget), applicable guidelines (ICH, regulatory) the company s SOP's and policies; Identify and manage internal and external partners with regard to the conduct of the clinical trials; Contribute to the trial specific document development (protocol, informed consent form, monitoring guidelines etc...) based on available templates; Manage trial budgets; Coordinate safety reporting.In addition, this individual will act as an ad hoc member of the Clinical Team and will give feedback on the CDP as required (i.e. planning, budget and progress of your clinical trial) as well as contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company's effort towards continuous quality improvement.Qualifications A minimum of a Bachelor of Science in Nursing, Pharmacy or Scientific Field is required or equivalent experience. A minimum of 5 years experience in Clinical Research and Development within the industry (pharmaceutical, biotech and/or CRO) is required. Previous project management (related to clinical trials) is required. Clinical monitoring experience is preferred. Previous international clinical trial, HIV experience, and vendor management is preferred. Kelly Scientific Resources is one of the many divisions under Kelly Services. Kelly Scientific Resources (KSR) provides staffing services on temporary and full time project based positions. KSR works on positions in industries such as Biomedical, Clinical Research and Pharmaceutical. Kelly Services is a fortune 500 company and an equal opportunity employer. Learn more about company