Study Manager
Fourth Technologies, Inc - New Jersey

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Successful candidate will primarily manage and monitor Phase I oncology studies managed by Clinical Pharmacology. Study management responsibilities include, but are not limited to • Protocol development, case report form development and informed consent writing; • Site identification and evaluation, ordering clinical supplies, and participation on study and project teams. • Monitoring clinical studies to ensure accurate data collection, protocol adherence, patient safety, PK and PD sample integrity, and GCP compliance. • Conducting study evaluation visits, study initiation meetings, routine monitoring and study close out visits. • Providing accurate drug accountability, achievement of on-time clean databases and for providing study progress reports to study and project teams. • Willingness and ability to travel is essential (annual estimate of 25% - 30% travel on average). • Prior experience in managing and monitoring Phase I oncology studies involving pharmacokinetic sampling and prior exposure to pharmacokinetic principles (e.g. course work) is required. Position Requirements for Study Manager: • BS Degree or equivalent education with 8 plus years of Healthcare experience (preferably pharmaceutical industry experience) of which 5 years include experience in Clinical Operations (Monitoring and Study Management). Of the 5 years of clinical operations experience, 3 years of monitoring experience and 2 years of study management experience is preferred. The ideal candidate(s) will have a solid clinical oncology background or be a research nurse with the following experience: • Study coordinator experience on Phase I clinical oncology trials in a hospital research setting (a General Clinical Research Center, for example); • Experience as a Study Manager/Clinical Trial Leader for a pharmaceutical company; • Experience as a CRA on Phase I oncology trials.

Fourth Technologies, Inc - 2 years ago - save job