Job Description:
Extensive knowledge of Nursing acquired through significant experience in a Senior Clinical role.
Demonstrable experience in qua..
Job Description:
Extensive knowledge of Nursing acquired through significant experience in a Senior Clinical role.
Demonstrable experience in quality, safety, and operational leadership with a clear focus on the development and sustainability of services from a quality, outcomes and experience perspective with a clear drive and passion for service change, quality improvement, delivery, and transformation.
Experience of meeting regulatory compliance standards and the provision, maintenance, and reporting of data to meet compliance.
Demonstrable experience of the ability to work autonomously, initiating and organizing workloads, delegating appropriately, responding to changing priorities and meeting tight deadlines.
Demonstrable experience of the ability to make difficult decisions autonomously.
Demonstrable experience in preparing and delivering Training to enable others to achieve quality and compliance standards across the company.
Establish new and revise existing quality procedures and tools in support of audit and compliance activities.
Identify quality process and system improvements and implement timely actions.
Assist the clinical development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management.
Collaborate with key stakeholders in the development and implementation of comprehensive internal (systems and procedures) and external (investigator sites and vendors) audit programs and plans.
Serve as a quality subject matter expert and provide guidance to development personnel performing investigations, root cause analysis, and capas through knowledge of quality concepts and techniques.
Participate on cross-functional teams as subject matter expert in GCP/GLP/GVP to provide guidance and risk-based options that promote compliance.
Identify and communicate quality and compliance risks and participate in determination of appropriate planning to resolve and address issues and risks.
Lead the strategy and activities in support of health authority GCP/GLP/GVP inspections.
Review clinical study documents and check for consistency and compliance with relevant regulations, standards, and best practices.
Coordinate projects to successfully meet timelines.
Job Requirement:
Registered nurse or enrolled nurse background with a passion for patient care.
Possesses the art of service excellence.
Experience in management of feedback and service recovery.
Well-versed in the operations of a service industry.
Ability to conduct on-the-job training (Service and Clinical).
Ability to initiate and implement Standard Operating Procedures.
