Clinical Study Manager

3-5 years Strong Project Management Regulatory submission experience Oncology experience Participate on a cross functional team focused on US regulatory submissions (FDA). Previous Pfizer experience is preferred; Pharmaceutical/biotech experience mandatory. Familiarity with U.S. NDA processes required Provides Financial Oversight Forecasts and manages high level clinical trial budget. Oversees the study risk planning process (e.g. IQMP) Works proactively with AP/CRO Supports Practical Clinical Trial Design o Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design. o Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed. o Facilitates early engagement of Alliance Partners/Vendors when needed. $70/hr 6 months 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.