Global Channel Management, Inc.
Clinical Study Manager
Global Channel Management, Inc., Township of Bernards, New Jersey, United States
Global Channel Management is a technology company specializing 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 regarding the skills and experience needed to fill the void of day-to-day functions. Organizations need to reduce training and labor costs while requiring the best "talent" for the job.
Qualifications The Clinical Study Manager position requires:
5 years of relevant experience with a BSc,
3 years with an MS/MPH, or
2 years with PharmD/PhD/MD.
Additional requirements include:
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/associate degree with substantial experience may be considered.
Experience in clinical or basic research within pharmaceutical, medical device/diagnostic companies, AROs, or CROs. CRA experience is preferred. Experience as a Study Site Coordinator is also relevant.
Clinical Study Manager duties include:
Developing a cross-functional, integrated study plan for study start-up (in-house), and managing the overall study implementation plan provided by the CRO. Participate in site selection and qualification.
Contributing to operational delivery aspects of the protocol, leading document review, and coordination for protocol amendments.
Performing additional medical writing tasks such as ICF, CRF guidelines, IB, safety communications, DSUR, and IND.
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Qualifications The Clinical Study Manager position requires:
5 years of relevant experience with a BSc,
3 years with an MS/MPH, or
2 years with PharmD/PhD/MD.
Additional requirements include:
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/associate degree with substantial experience may be considered.
Experience in clinical or basic research within pharmaceutical, medical device/diagnostic companies, AROs, or CROs. CRA experience is preferred. Experience as a Study Site Coordinator is also relevant.
Clinical Study Manager duties include:
Developing a cross-functional, integrated study plan for study start-up (in-house), and managing the overall study implementation plan provided by the CRO. Participate in site selection and qualification.
Contributing to operational delivery aspects of the protocol, leading document review, and coordination for protocol amendments.
Performing additional medical writing tasks such as ICF, CRF guidelines, IB, safety communications, DSUR, and IND.
#J-18808-Ljbffr