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HIM Director
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- Set vision and strategy for expanding regulatory teams that include both staff recruitment and retention strategies, and portfolio expansion strategies.
- Establish and operationalize policies, Standard Operating Procedures (SOPs), and quality assurance processes that ensure program compliance; partner with CRS Compliance and Regulatory Affairs Program to align with existing policies and systems.
- Partner with Clinical Research Management (CRM) to establish and maintain well-defined work flows, roles and responsibilities, and communications to ensure effective integration between regulatory and clinical operations.
- Oversee management and system support for an enterprise-wide eRegulatory and eSubject management system, Florence, including on-boarding, training, SOP management, user group engagement, trial migration, and quality control.
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