Study Manager (Insourced to MNC)

Job Description:

• Accountable for conducting country and study level feasibility, review Pre-Trial Assessment (PTA) output to ensure appropriate site selection in China.

• Provide comprehensive operational input to the protocol design to ensure operational feasibility.

• Accountable for the development of realistic detailed study startup and monitoring plans.

• Develop study level recruitment/retention strategy/plan; oversee implementation of plan, including site-level plans, recruitment/retention tools, and advertising materials.

• Assess and oversee site activation plans to ensure timely site readiness (Clinical Site Agreements, Ethics Committee approvals and regulatory documentation.)

• Provides ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting for financial planning.

• Generate study/country level ICD and review site level ICD as appropriate.

• Accountable for the delivery...