Clinical Research Manager manages the team responsible for the design, administration, and execution of clinical research trials. Monitors and ensures adherence to established processes and procedures, FDA regulatory requirements, Good Clinical Practice (GCP) research standards, and JCAHO and International Conference on Harmonization (ICH) guidelines. Being a Clinical Research Manager may assist with the development and implementation of clinical processes, procedures, and programs. May require a master's degree. Additionally, Clinical Research Manager may require ACRP or SOCRA certification. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes.
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