Associate Director, Clinical Operations
Provides leadership, direction and management to Clinical Operations staff in the assigned area. Provides training, consultation and oversees quality related for operating activities of assigned staff to ensure project deliverables are met. Acts as primary point of contact for resourcing escalations, assuring utilization, performance and development of Clinical Operations staff. May liaise with other departments or business units to optimize resources as well as to establish harmonize clinical operations practices, processes and tools. Contributes to operational initiatives.
- Bachelor's degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required.
- Extensive knowledge of and experience with GCP/ICH guidelines and other applicable regulations.
- Demonstrate strong leadership, tactical and strategic thinking skills. Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas. Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.
- Ability to understand, explain and communicate project concepts and put into detailed plans. Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.
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