Clinical Trial Manager Oncology Posted June 23, 2006 Five Years Experience East Hanover New Jersey

JOB DESCRIPTION: -Provide operational expertise and lead multidisciplinary teams to deliver high quality program milestones on time and within budget. -Prepares and reviews Clinical Protocol Summaries and Clinical Trial Protocols. -Prepares / reviews Clinical Trial Reports and Summaries. -Provides clinical research and operational expertise in the development of overall strategy and objectives of clinical plan. -Preparation and implementation of project specific training programs and training materials for internal and external staff. -Participates in cross-functional teams in support of continuous improvement and other management objectives. -Main contact for operational execution / development of program. -Leads and develops CRS/SrCRs with execution of trials. -Provides weekly / monthly reports regarding clinical study budgets / timelines JOB REQUIREMENTS: -University degree in Biological Sciences/Nursing /Pharmacy. -Demonstrated ability to write protocols and Clinical Trial Reports independently. -Medical-scientific writing skills. -Ability to recognize safety and efficacy data trends independently. -Knowledge of clinical trial design, statistics and pharmacokinetics. -Familiar with all aspects of the drug development process. -Knowledge of the medical, scientific and clinical research techniques of the assigned areas. -Knowledge of GCP and local regulatory requirements. -Effective oral and written communication skills. -5 years of experience in clinical environment