Clinical Study Manager

Global Channel Management, Inc.; New York (NY); 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 still requiring the best talent for the job.

Qualifications

1. 3-5 years of experience
2. Strong Project Management skills
3. Regulatory submission experience
4. Oncology experience
5. Participate on a cross-functional team focused on US regulatory submissions (FDA)
6. Previous Pfizer experience is preferred; Pharmaceutical/biotech experience is mandatory
7. Familiarity with U.S. NDA processes required
8. Provides Financial Oversight
9. Forecasts and manages high-level clinical trial budgets
10. Oversees the study risk planning process (e.g. IQMP)
11. Works proactively with AP/CRO
12. Supports Practical Clinical Trial Design
1. Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design
2. 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
3. Facilitates early engagement of Alliance Partners/Vendors when needed