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Clinical Study Manager

Global Channel Management, Inc.
New York, New York, United States
November 28, 2016

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.