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Career Opportunities
Associate Manager/Manager - Clinical Operations - SHKA-ER (EGC) | Clinical Operations
Eisai Medical Research Inc. -- Ridgefield Park, New Jersey | | | Job Description- Responsible for ensuring that the therapeutic area is meeting EGC's short- and long-term goals with respect to monitoring/management of clinical trials in the SHKA-ER clinical operations group
- Must have the technical capabilities and expertise to lead large global or multiple clinical studies within the group from protocol development and study management, to final analysis and submission within a therapeutic area
- Responsible for identifying potential challenges, working with the team to strategize possible solutions, and for developing sound knowledge of a number of areas in the drug development process, including clinical plan development, study area and execution of the clinical study chain
| Qualifications- Minimum of a Bachelor of Science degree in relevant scientific discipline
- 5+ yrs experience in pharmaceutical industry, including managing outsourcing to CROs and multiple vendors
- Phase III Study experience desirable, GI area preferred
- Working knowledge of entire drug development process, including clinical plan development and execution of entire clinical study plan
- Detailed knowledge of Code of Federal regulation (CFRs), ICH guidelines, project management and corporate/ regional SOPs
- Good organizational skills, time management and attention to detail
- Extremely proficient computer skills including MS Word, Excel and PowerPoint
- Strong verbal, written and interpersonal communication skills, especially in a cross functional team environment, leading study teas as required
- 20% travel required
- Eisai is an Equal Opportunity Employer
Date Posted12/14/2007 |
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