Senior Clinical
Research Scientist
(Oncology Area)
Posted June 23, 2006
1 to 3 Years Experience
Florham Park, NJ
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JOB DESCRIPTION:
Responsible for management and implementation /execution of sponsor and Investigator-sponsored Phase II/IV non-registration clinical trials in Oncology. The CRS/SCRS is expected to manage CROs, internal support teams (medical writers, statistician, data manager) and clinical supplies; track study budgets; process and report adverse events; assist in development and review of clinical protocols, study reports, and manuscripts; implement project specific training program for internal & external staff; prepare manuscripts and abstracts in collaboration with the senior clinical team. The emphasis of this position is on high level project management. There are no direct site monitoring responsibilities. Travel, when necessary, to potential and/or ongoing Investigative sites, as well as Investigator and Advisory Board meetings in the assigned therapeutic area or other meetings as required. Other duties as defined by supervisor.
JOB REQUIREMENTS:
Bachelors degree in Biological Science and at least 2 years experience in the pharmaceutical industry. Advanced degree is desirable (Pharm D, PhD, RN, MS/MBA). Oncology specific experience preferred. Knowledge of clinical trial design, analysis, and reporting, site management, initiation and tracking, grant payment set-up is critical. A thorough understanding of the drug development process including all applicable FDA regulations and GCP’s is required. Experience initiating and managing Investigator-Initiated trial highly desirable. In addition, experience in writing and reviewing final study reports would be useful. Excellent communication, presentation and writing skills necessary.
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