Clinical Quality Manager Resume Sample
Faye Herman
2180 Monahan Shores,
New York,
NY
+1 (555) 449 1061
Work Experience
Clinical Quality Manager
03/2016
-
PRESENT
Chicago, IL
- Demonstrates the Telecare mission, purpose, values and beliefs in everyday language and contact with internal and external stakeholders
- Promotes and maintains harmonious and effective relationships and communications within the department and other departments
- Coordinates the clinical activities of senior program staff (Administrators, DON's, Clinical Directors) working on special assignments, from the Chief of Clinical Quality, outside of their own program responsibilities
- Provides individualized program assistance, leading in-depth system analysis, development of improvement plans, implementation and re-evaluation. This includes clinical, administrative and environmental reviews
- Identifies organization-wide training needs through analysis of the Quality Review Process and coordination of findings with the CCQ and Directors of Training
- Supports the efforts of the standardization process for Telecare programs
- Plans Focused Review Process for programs determined by Chief Clinical Quality and the Risk Management Team to be at greater operational risk through analysis of clinical indicators, critical incidents, and / or other indicators that identify risks
Clinical Informatics Quality Manager
10/2012
-
12/2015
Philadelphia, PA
- Consults directly with CCQ to develop operational plans specific to the strategic priorities and identified initiatives of the Operations team
- Accurately reports the status of clinical care to the administrators, CCQ and operations
- Plans and organizes the startup, orientation and operations of new business with the nursing policy and procedures
- Develops and implements training specific to quality related issues and the quality review process
- Coordinates activities within the allocated budgetary parameters and participates in the development of the fiscal budget specific to the role within Operations budget
- Demonstrates initiative in improving Telecare’s services to its members served
- Demonstrates commitment to Quality Improvement principles in all day to day activities
- Provides consultation to the programs pertaining to the performance improvement process, including training, team support, measurement and analysis, documentation, evaluation and reporting
- Provides consultation to the program staff
Manager Auditor Clinical Quality Management
02/2007
-
04/2012
Philadelphia, PA
- Participates / consults with CCQ and/or members of the Risk Management Team in identifying, analyzing, evaluating and reporting quality improvement initiatives
- Manages the analysis, determination, and disposition of clinical quality reviews. Ensures there is consistency in processing potential quality issues and that CQM contract requirements and standards are met. Monitors cases entered in the Clinical Quality Management Data System for accuracy, completeness, clarity, and timeliness
- Supervises QM coordinators. Implements improvement plans as necessary. Provides education, training, consultation, and support necessary to ensure successful performance
- Assist with the oversight and management of Inovalon’s training processes (both initial and ongoing training) for all review personnel
- Lead the design, build and implementation of a new rules engine to generate clinical insights essential to improving quality of care
- Manage Temporary staff hired to support production, aka, hybrid chart chase
- Owns key Corporate CAPA’s, leads cross divisional teams in addressing compliance issues using CAPA tools/processes
Education
Grand View University
2003 - 2007
Bachelor's Degree in Life Sciences
Professional Skills
- Oversee the maintenance of clinical records and files to comply with Conditions of Participation (COPs), using measurements, as licensure, certification, and accreditation results
- Solid written and verbal communication skills, analytical and problem solvingskills
- Flexible, highly motivated, with strong organization skills and the ability to multitask
- Strong communication skills; Expert level oral and written English
- Experience working with HEDIS vendors, demonstrated ability specific to management, building relationships, issue resolution etc
- Proven experience working in a pharmaceutical or medical device setting
- Experience of Quality experience in a managed care setting
How to write Clinical Quality Manager Resume
Clinical Quality Manager role is responsible for analytical, training, integration, auditing, reporting, design, research, insurance, travel, software.
To write great resume for clinical quality manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Quality Manager Resume
The section contact information is important in your clinical quality manager resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Clinical Quality Manager Resume
The section work experience is an essential part of your clinical quality manager resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous clinical quality manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical quality manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Quality Manager resume experience can include:
- Quality Liaison: Serve as a leader in cross-functional meetings to accomplish quality improvement and quality compliance goals and serve as a liaison for regulators or other community-based organizations as needed
- Excellent communication skills with all levels of internal/external staff, management, members, physicians/physician office staff, vendors, etc
- Effectively utilizes time and resources
- Strong problem-solving abilities. Ability to identify issues and problems within clinical and administrative activities
- Handle various situations in a professional manner, demonstrating excellent customer service at all times and ability to adapt to change
- Drafts MOC revisions and reviews with Clinical/Operational leads prior to review with health plan/submissions to CMS
Education on a Clinical Quality Manager Resume
Make sure to make education a priority on your clinical quality manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical quality manager experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Clinical Quality Manager Resume
When listing skills on your clinical quality manager resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical clinical quality manager skills:
- Detail orientation; strong analytical and organizational skills
- Strong written & verbal communication skills and the ability to work well with internal and external stakeholders
- In industry (Pharmacy, Chemistry, Cosmetics, Food Processing, Medical Devices) and solid experience in Clinical Quality auditing
- At least eight years of Clinical Quality experience with Clinical Trial management experience in a pharmaceutical/medical device company
- Prior knowledge of quality measurements (HEDIS, Pay for Performance, PQRS, etc.) and experience using the scores to improve care
- Advanced computer proficiency and skills in MS Excel, PowerPoint, Word, Outlook and SQL required
List of Typical Experience For a Clinical Quality Manager Resume
1
Experience For Clinical Informatics Quality Manager Resume
- Related clinical / QA / GCP experience within the pharmaceutical industry
- Conducting audits and meeting the following requirements
- Assisting in the development and implementation of the annual QA-GCP audit plan using a risk-basedapproach
- Conducting GCP Risk Assessments
- Developing an audit agenda and communications (e.g., pre-audit document requests) with auditees for each assigned auditproject
- Facilitates health plan quality committees by either participating as appropriate or making formal presentations
2
Experience For Project Manager, Clinical Quality Assurance Resume
- Serves as interface for inspections audits and inspections relating to GCP compliance
- Assist in collecting Quality metrics
- Knowledge and understanding of medical management
- Implements the SNP program Model of Care (MOC), including Transitions of Care (TOC), as required for each individual SNP MOC
- Assist with the implementation of the National HEDIS® improvement plan, including the HEDIS® data collection and clinical improvement projects
- Assist with the implementation of the National HEDIS® improvement plan, including the HEDIS data collection and clinical improvement projects
- Track and assess all CAPA documentation and implementation as needed, ensuring all parties follow through with their respective actions
- Interpret relevant regulations and apply them to clinical R&D programs through consultation and training
3
Experience For Manager Auditor Clinical Quality Management Resume
- Lead and/or participate in the planning, conduct and follow-up of Regulatory GCP inspections
- Assess inspection readiness and contribute to development and delivery of Inspection Readiness training for cross-functional team members, as needed
- Maintain ongoing awareness of program and study issues related to quality, safety and efficacy
- Evaluate audit/inspection trends and other information sources to support audit planning and optimize clinical trial quality and compliance
- Monitors employee productivity and provide constructive feedback, coaching and identifies personal growth opportunities
- Plans and monitors quality activities for Clinical Trials
- Proactively anticipate the horizon of regulations and make sure that current GCP/Clinical Trial practices reflect current and future industry practice
- Performs Clinical site / vendor audits as required
- Provides Clinical quality leadership regarding, interpretation of clinical regulations, answers questions, able to make quality recommendations to Clinical Operations as required. Provides Clinical Quality leadership, expertise, and support
4
Experience For Manager, Clinical Quality Assurance Resume
- Maintains current and leading edge expertise in quality management systems and quality techniques
- Maintains a high level of expertise in current regulatory requirements and technical issues
- Design, update and maintain internal and external audits and documents review program
- Seeks from clinical operations information required to elaborate and maintain
- Read and comprehend documents of a moderately complicated nature
- Able to understand and apply the appropriate specifications for numerator and denominator, and exclusion criteria for quality measures
- Develops measurable indicators of quality for quality projects. Works with data analysts to collect administrative data. Performs the analysis and reporting of clinical quality projects, including compliance to clinical practice guidelines, including standards of national accrediting agencies for ambulatory care
5
Experience For PRN RN Manager of Clinical Practice & Quality Assurance Resume
- Participates in the selection of the organization Specialty Physicians and Primary Care practitioners’ quality measurements, working collaboratively with the Department Chairs and Division Directors of the departments and participates in the chart reviews as needed
- Conducts the Medical Staff department’s annual review of quality measures within the timeframe designated to provide physician feedback to be used in the physician’s performance evaluation for aggregate level and physician specific rates
- Monitors the quality of care and service delivered at the various locations of the multi-specialty group practice, including the patient satisfaction results and trending of complaints related to quality
- Participates with the development, implementation and coordination of policies, procedures and protocols that ensure compliance with legal and other external regulations/requirements to support the continuous performance improvement of the quality of care and service provided by the organization
- Works collaboratively with major payers’ Quality Management Departments on clinical and service quality improvement activities
6
Experience For Hedis Clinical Quality Manager Resume
- Coordinates the activities of the department to ensure effective dovetailing of efforts with the other nurse analyst(s) and with the other members of the OMD team, including the data analysts, case managers, and division of drug management services
- Represents the quality nurse analysts at appropriate committee meetings, including the Clinical Practice Committee and the Risk Management Committee, and other meetings as needed. Creates and files minutes for the Clinical Practice Committee
- Utilize extensive knowledge of Lean/Six Sigma to lead cross-functional process improvement projects focused on Clinical Quality measurements
- Generates reports for the Director of Quality and presents data/reports to the EQC
- Completes annual written review of each program
- Ensures Part C and HEDIS submissions are completed for all SNPs; monitors Part C (Assessment and reassessment) and completes monthly
7
Experience For Clinical Audit Quality Manager & Internal HBA Resume
- Prepares for, coordinates, and participates in Delegation Audits; ensures deficiencies are addressed and audits on an ongoing basis for completion and compliance with CAP within specified timeframes
- Obtains CAHPS patient survey results from Health Plans for review in QI meetings, identifying areas for improvement; assists the team in plan development
- Develops/implements SNP/ESCO specific policies and procedures and conducts educational programs regarding compliance and regulatory issues
- Coordinates quality improvement projects as determined by departmental or organizational needs
- Provides MOC and TOC education for new Directors and ROMs
8
Experience For Clinical Nurse Analyst / Quality Manager Resume
- Attends Quality improvement meetings
- Deals with confidential information and/or issues thoughtfully with discretion
- Participate with Regional Quality Team to identify and implement region and or state-specific projects to improve HEDIS® scores, CMS Star Ratings and other metrics
- Manage temporary staff hired to support hybrid chart chase
- Identify opportunities for Rate Maximization to achieve optimal Hybrid rates
9
Experience For Clinical Guidance Quality Manager Resume
- Vendor Oversight at the Project/Market level
- Participate in determination of annual HEDIS® strategy as well as other clinical improvements
- Collaborate with the QSD Project Managers in the collection of RFI, ROADMAP and HOQ information for HEDIS®
- Manage & perform an auditing schedule that encompasses all phases of clinical studies, including authoring/updating study specific audit program documentation for projects and preparing, writing, and distributing reports
- Support GCP & GcLP regulatory inspections internally, and at investigator sites, CROs, bioanalytical labs, etc. for US submissions and studies. Prepare, coordinate and track all document requests, responses, and supporting documentation during inspections and verify appropriate response post-inspection
- Develop QA policies, procedures and standards, and track/manage the review process of both local and global QA SOPs, ensuring adherence to regulatory guidelines
- Solid understanding of clinical operations, GCP / ICH regulations, and QA items such as CAPAs, inspection readiness, gap analysis, audits, etc
- Collaborate with global QA teams and other internal groups cross-functionally to develop and implement GCP quality objectives and audit schedules
10
Experience For Clinical Quality Manager Resume
- Manage the implementation and successful completion of the Medicaid and Medicare quality improvement program
- Support member care gap closures through working with physician practices, Quality Improvement Interventions: Responsible for maintaining or improving performance upon contractual and nationally required quality performance metrics, including HEDIS and customized state measures
- Identify and prioritize key quality and utilization initiatives critical for the success of performance based payment programs. Management of external contractors: Oversight of external contractors such as HEDIS contractor as needed
- Prepare and present reports and updates at internal and external provider related meetings
- Plan, manage and perform GCP audits of Contract Research Organizations (CROs), systems/processes and clinical Investigator sites for Phase 1 to 4 clinical trials
- Prepare audit reports and communicate findings to auditees, study team representatives and management
List of Typical Skills For a Clinical Quality Manager Resume
1
Skills For Clinical Informatics Quality Manager Resume
- Leading Clinical Quality Management Reviews (summarizing quality audits, deviations and CAPA trends for Altria leadership and our Clinical Operations group). Presenting clinical quality updates at CRO and bioanalytical lab governance review meetings
- Experience with analyzing problems, drawing conclusions and devising appropriate courses of action
- Flexibility to manage shifting demands and changing priorities, proactively looking for ways to contribute
- Experience working with HEDIS® software vendors (management, building relationships, issue resolution etc.)
- Experience preparing and analyzing quality data
- Experience managing and implementing quality improvement programs
- Experience with determining strategic direction and developing tactical plans
- Experience with conveying and interpreting complex information in a manner that others can understand
2
Skills For Project Manager, Clinical Quality Assurance Resume
- Experience supervising or managing staff
- Extensive working knowledge of international regulations, guidelines and good practices pertaining to clinical trials required
- Experience working collaboratively across different teams
- Experience in clinical research and/or a GCP-related environment, with at least 3 years of clinical quality assurance auditing required
- Be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamicenvironment
- Quality Assurance experience in the biotechnology and/or pharmaceutical industries required
3
Skills For Manager Auditor Clinical Quality Management Resume
- Past management experience; and
- Strong knowledge of GCP regulations and guidelines
- Healthcare / Health Plan experience
- HEDIS experience and / or medical record review
- Leading, developing, and managing CRO Quality Agreement responsibilities
- Evaluating and reviewing clinical trial deviation trends to ensure appropriate investigations are conducted
4
Skills For Manager, Clinical Quality Assurance Resume
- Participating in quality management system (GLP, GCP) audits to oversee supplier audit practices
- Leading and coordinating assessment of Clinical Operations
- Leading or participating in corrective actions and programs designed to enhance the quality and compliance of the organization
- Developing audit schedules and conducting/coordinating supplier GCP/GLP audits including, CRO, clinical site, and bioanalytical audits. Reviewing supplier data integrity program
- Working in managed care quality department in Medicaid / Medicare or equivalent experience in non-managed care setting
- Build trust and form effective relationships with stakeholders by providing timely operational updates, partnering on issue resolution / mitigation strategies
- Leading preparation of GCP and GLP- related inspections by regulatory authorities, including participation in the preparation of responses to external regulatory inspections
5
Skills For PRN RN Manager of Clinical Practice & Quality Assurance Resume
- Experience working with Providers / Provider Groups
- Experience with providing FDA, ICH and other regulatory guidance to support clinical team’s preparation for agency inspections
- Knowledgeable in Clinical Trial regulations domestic and international including; 21 CFR Parts 50, 54, 56, 58, 312 & 812 for Clinical Trials
- Intermediate proficiency with Microsoft Office applications, including: Word, Excel and PowerPoint
- EDocument Management, Training, CAPA’s, Audit systems and tools
- Reviews, edits, and approves changes to standard operating procedures
6
Skills For Hedis Clinical Quality Manager Resume
- Are with Clinical QA/ GCP auditing experience across a broad range of audit activities (e.g., clinical sites, vendors (clinical CROs), and internal systems
- Experience supervising / managing staff
- Experience with Microsoft Excel,
- Relevant experience in clinical research
- Five years of experience in Clinical Quality Assurance
- Excellent verbal and written communication skills; ability to speak clearly and concisely, conveying complex or information in a manner that others can understand, as well as ability to understand and interpret complex information from others
- Experience leading inspection-readiness activities resulting in successful FDA inspection
- Knowledge and experience in GCP, ICH, local and international regulations
7
Skills For Clinical Audit Quality Manager & Internal HBA Resume
- Demonstrated ability to work independently and flexible in a fast-paced, high growth environment
- Familiar with computer validation and 21 CFR Part 11
- Also knowledgeable with ICH E6 Good Clinical Practice
- Anticipate future changes in Clinical Trial Regulations
- Identify regulatory and quality risks and proactively identify areas of concern
- Attention to detail as well as a crisp, clear and concise style in written and oral communications
- Membership in the Society of Quality Assurance (SQA) or American Society of Quality (ASQ) along with CQA, CQM, or CQE certification desired
- A designated quiet workspace in your home (separated from non-workspace areas) and is able to be secured to maintain Protected Health Information (PHI) and/or Protected Information (PI)
8
Skills For Clinical Nurse Analyst / Quality Manager Resume
- Three or more years’ experience in outpatient clinical care, preferably in a medical management environment
- Experience with Internal and vendor audits
- Knowledge of validation principles
- HEDIS® experience and/or knowledge
- Healthcare/Health Plan experience
- HEDIS® experience and/ or knowledge
9
Skills For Clinical Guidance Quality Manager Resume
- Clinical and/ or Health Education experience (RN or LPN desired)
- Healthcare experience
- Quality improvement experience
- Experience in health plan data and outcomes measurements related to regulatory requirements
- Experience with MS Word, Excel, PowerPoint
10
Skills For Clinical Quality Manager Resume
- Experience with EMT optimization and clinical data integration
- Experience in a manager or supervisor position
- Clinical experience as an LPN or RN
- Experience in Performance Improvement Projects
- Experience with State Medicaid Contracts
- CGMP pharmaceutical, medical device regulations, guidelines, and standards related to Quality systems
- Cleanroom and laboratory equipment maintenance
List of Typical Responsibilities For a Clinical Quality Manager Resume
1
Responsibilities For Clinical Informatics Quality Manager Resume
- Demonstrates critical thinking, sound judgement, and initiative to solve problems
- Maintains tracking and trending of quality metrics
- Review and assess audit report responses and ensure that corrective and preventative action (CAPA) plans adequately address findings and root cause analysis
- Evaluate, track and follow up on CAPAs to ensure actions are adequately completed in a timely manner
- Contribute to assessment of reports and results from Regulatory Inspections
- Assist in preparation of response documents for Site Inspections and Sponsor/CRO Inspections
2
Responsibilities For Project Manager, Clinical Quality Assurance Resume
- Lead efforts for completion of inspection follow-up activities
- Participate in regular study team meetings and provide quality oversight and consultation at program/study level
- Provide risk identification/mitigation support for potential and/or identified quality issues
- Provide GCP compliance consultation on process enhancement/compliance and quality issue management
- Appropriately escalate quality/compliance issues to management
3
Responsibilities For Manager Auditor Clinical Quality Management Resume
- Maintain current industry knowledge of applicable regulations, guidelines, and company standards
- Evaluate impact of new regulations/guidance, as well as audit results/trends on the business and regulatory risks and provide guidance
- Contribute to the identification and communication of lessons learned from audits and inspections
- Travel as needed, up to 30% domestic and internationally
- Independently or within a committee reviews and determines acceptability of CAPAs
- Acts as a Global Quality liaison to one or more Otsuka business functions and/or project teams
4
Responsibilities For Manager, Clinical Quality Assurance Resume
- Certified quality auditor (CQA) credentials
- The ability to travel up to 30% throughout the year (domestic and international)
- CPHQ or CHCQM OR ability to obtain within one year
- Excellent verbal and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members
- Perform all essential functions of the position, with or without reasonable accommodation
5
Responsibilities For PRN RN Manager of Clinical Practice & Quality Assurance Resume
- Manage the Audit Program dedicated to clinical development activities
- Perform External and Internal Audits and independent reviews of documents
- Act as a Quality representative for the SIG’s clinical activities
- Acts as GCP Subject Matter Expert for clinical activities
- Contribute to the development and optimization of the Clinical Quality Management System
- Applies knowledge of current and emerging regulations, standards, or guidance documents to ensure that current processes and operational techniques follow FDA regulations and Good Manufacturing Practices (GMP)
6
Responsibilities For Hedis Clinical Quality Manager Resume
- Executes change control, vendor qualification and risk analysis
- Identifies and implements quality system continuous improvement
- Produces a detailed comprehensive documentation of quality control analysis and make appropriate recommendation based on data
- Manages site specific non-conformances, investigating and closing of deviations, and Corrective Action-Preventive Action (CAPAs). Reviews, edits, and approves changes to standard operating procedures
- Responsible for batch record issuance and release
7
Responsibilities For Clinical Audit Quality Manager & Internal HBA Resume
- Oversees and maintains records of component acceptance activities for management review
- Responsible for producing documentation required for internal and vendor audits. Assists management in the case of federal regulatory agencies during audits and/or inspections
- Conducts cGMP training for the all departments in the Pittsburgh site. Works with senior management to develop and implement the site specific training activities. Responsible for record maintenance of all annual compliance training activities
- Assists with managing the electronic documentation management system (EDMS) with regard to back end system administration, information input, distribution, user access, reports, and document retrieval
- Support implementing and executing the Validation Master Plan
- Experience of internal and external audits in an international environment
8
Responsibilities For Clinical Nurse Analyst / Quality Manager Resume
- 20-30% domestic and international
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts
- English fluent written and oral
- Knowledge of regulatory requirements and/or accreditation standards desired
- Inventory control processes
- HEDIS Production Season
- Adheres to the organization’s policy on Confidentiality and HIPPA regulations, which protects the privacy of member information and records. Responsible for protection of information and documentation related to the peer review process, which prohibits the release of any identifiable medical information or inappropriate disclosure of such information
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