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Clinical Study Manager

Global Channel Management, Inc. · Bernards, NJ, United States

On-site / hybridOther 3419 days ago

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About the job

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation.  Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function.  Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Clinical Study Manager needs 5 years relevant experience is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD Clinical Study Manager requires: - Phase II/III Oncology trial experience strongly preferred - Global trial experience strongly preferred - Experience working in both sponsor and CRO organizations strongly preferred - Candidates with a nursing diploma/assoc degree with substantial experience may be considered for this position. - clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. Clinical Study Manager duties are: - Develop project cross-functional, integrated study plan to study start up (in-house) and validate and manage to the overall study implementation plan provided by the CRO. Participate in site selection and site qualification with (study team and CRO). - Contribute to operational delivery aspects of the protocol and lead document review & coordination for the protocol and amendments. - Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. $57/hr 6 months