Biosimilars – Manager Study Management

1 month ago


Redlands, United States ICONMA Full time

· Global biosimilar development operational execution through oversight of cross functional trial activities in partnership with CRO.

· Ensuring implementation of trial(s) in partnership with CRO in accordance with applicable SOPs and ICH/GCP guidelines.

· Execution of clinical studies with high-quality, on time, and within budget.

· Contribute to the authoring and review of key study documents.

· Day to day management of study execution including management of study timelines.

· Managing program-level operational issues and oversight of study team issue escalation.

· Supports / Leads the Global Clinical Study Team for the allocated program(s).

· Communicating global status of clinical study programs to senior management.

· Contributing to initiatives and process improvement work streams, including process mapping of CROs.



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