Clinical Study Manager

Global Channel Management, Inc.; Bernards Township (NJ); On-site; USD 60,000 - 80,000; Full time

Job description

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 while requiring the best talent for the job.

Qualifications

Clinical Study Manager requires 5 years of relevant experience with a BSc, 3 years with an MS/MPH, or 2 years with a 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/associate degree with substantial experience may be considered for this position.
• Clinical or basic research experience in a Pharmaceutical company, 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.

Responsibilities

Clinical Study Manager duties include:

• 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 the study team and CRO.
• Contribute to operational delivery aspects of the protocol and lead document review and coordination for the protocol and amendments.
• Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.