Roles & Responsibilities
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.
· Ability to display mentorship skills.
