Clinical Manager (98776)

SECTION 1: Job Summary (Summary of the basic functions of the position)

The Clinical Manager is responsible for the development, implementation and evaluation of surgical
and clinical quality management strategies and initiatives. These initiatives involve quality
improvement, patient safety, risk management, emergency measures programs and systems in support
of the mission of delivering high standards of quality and clinical excellence. The manager will set the
performance and cultural bar for clinical quality for the entire practice under the direction of the
Practice Manager.

SECTION 2: Duties and Responsibilities (Responsibilities necessary to accomplish job functions)

• Oversight of the planning, execution, and reporting of audits of clinical investigational sites and central/contract facilities, to ensure that studies of investigational products are conducted in accordance with Good Clinical Practice (GCP) standards, and local and federal regulations.
• Function as lead auditor when performing audits and authoring audit reports.
• Provide compliance support related to internal company activities and act as a resource for the Clinical Department.
• Coordinates GCP audit activities for sites, data bases, and reports.
• Coordinates Quality Assurance review of clinical study reports.
• Provide compliance support during regulatory inspections of the company, investigational sites or cooperative partners as applicable.
• Develops quality assurance plans by conducting hazard analyses; identifying safety issues and preventative measures; monitoring procedures, corrective actions, and verification procedures in collaboration with staff and physicians.
• Validates quality processes by writing and updating quality assurance policies and procedures.
• Serves as QI Coordinator for the organization, preparing quarterly reports and holding QI committee meetings with results reported to physicians.
• Serves as the expert resource on regulatory/accreditation and licensure standards and expectations for compliance.
• Designs and implements a systematic approach to ensure a high level of awareness of regulatory and accrediting agency requirements including ramifications of failures in compliance.
• Provides central expertise regarding accreditation and licensure standards. Identify, plan for, communicate, monitor and evaluate actions to comply with existing and new regulations, standards and accreditation requirements.
• Timely analysis of regulatory materials, journals and newsletters for implications on operations.
• Provides leadership in preparation and readiness for regulatory and accreditation surveys.
• Implements a periodic organizational needs assessment for regulatory compliance including periodic performance reviews.
• Recommend and/or develop new policies to ensure compliance with regulatory and professional standards.
• Serves as liaison to regulatory agencies bodies.
• Provides documentation and other information as required or requested on time to assure compliance for regulating agencies.
• Maintain and organize all critical documentation support in compliance with requirements.
• Recommend and/or develop new policies to ensure compliance with regulatory, and professional standards.
• Manage all agency/regulatory bodies site visits to include scheduling, logistics and communication within medical center.
• Oversee the development of delivery and follow-up documentation (i.e. reports, plans, appeals, etc.)
• Provides consultation to departments on the interpretation and application of accreditation/clinical QI standards.
• Assist supervisors in the development of specific educational materials to address areas of vulnerability for compliance with standards or unique requirements for special accreditations.
• Assist the medical center to review all educational materials for regulatory or accreditation compliance to assure they reflect practice and congruency with each other.
• May contribute to long-term strategic development and planning of a project or functional area.
• Partner with Regional Practice Manager to develop, implement and sustain clinical