Clinical Manager - Plastic Surgery

U.S. Dermatology Partners; Overland Park (KS); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

U.S. Dermatology Partners seeks a Clinical Manager to drive surgical and clinical quality management strategies across the practice. The role focuses on quality improvement, patient safety, risk management and regulatory readiness to uphold high standards of care.

The position requires leading audits, developing QA plans, and coordinating regulatory activities. You will supervise clinical staff and collaborate with regional managers to maintain quality systems and compliance across centers.

Formación

• Knowledge of GCP standards and local/federal regulations.
• Experience leading quality improvement initiatives.
• Strong leadership and cross-functional collaboration skills.

Responsabilidades

• Oversee audits of clinical investigational sites and facilities for GCP compliance.
• Lead audit reports and provide regulatory compliance support to the Clinical Department.
• Coordinate GCP audit activities for sites, databases, and reports.
• Develop quality assurance plans, hazard analyses and corrective actions.
• Prepare regulatory and accreditation documentation and readiness activities.
• Supervise clinical and aesthetics staff and manage recruitment, scheduling and performance reviews.

Conocimientos

Quality management

Regulatory compliance

Auditing

Leadership

GCP knowledge

Descripción del empleo

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 strategies and tactics.
• Partners with Regional Practice Manager, Clinic and Surgery Supervisors, Human Resources, Revenue Cycle Manager and corporate staff to build and maintain clinical quality.
• Works with Quality Assurance committee and other internal departments to assure appropriate consistency in quality systems (e.g., training, auditing, data review).
• Serves as direct supervisor for all clinical and aesthetics staff.
• Responsible for recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling and disciplining employees; communicating job expectations; planning, monitoring, appraising and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures to ensure quality staff.
• Contributes information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, completing audits; determining system improvements; implementing change.
• Maintains and improved product quality by completing product, company, system, compliance and surveillance audits and investigating customer complaints.
• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions and re-validations.
• Updates job knowledge by studying trends and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Develop working relationships with external agency representatives and key contacts to assist understanding of medical center compliance requirements.
• Identify areas of vulnerability and assist area leaders in developing corrective action plans.
• Identify areas of success; celebrate and encourage promotion of best practices.
• Review, assess, and work to revise relevant policies and procedures to ensure compliance with regulatory, accreditation and professional standards.
• Development of new employee orientation materials and mandatory educational materials to meet annual requirements, in collaboration with supervisors
• Relationships with staff in all areas are fostered to meet goals and objectives of excellence in quality of care.
• Positive working relationships with peers, management and customers are maintained at all times.
• Organizational Mission and Values of Respect, Integrity, Stewardship and Excellence are evident in behaviors.
• Participates in performance improvement activities.
• Adheres to all safety policies and procedures in performing job duties and responsibilities while supporting a culture of high quality and great customer service.
• Performs other duties that may be necessary or in the best interest of the organization.