Clinical Quality Manager Job Description
Clinical quality manager
provides advice, guidance to stakeholders on Quality, Safety & Environment related topics based on standards, regulatory requirements, code of practices, guidelines and technical requirements;.
Clinical Quality Manager Duties & Responsibilities
To write an effective clinical quality manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical quality manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Develop GCP related quality system SOPs in compliance with all applicable regulatory requirements, aligning with existing company policy
Ensure clinical trials are performed in accordance with study protocols and are in compliance with all applicable regulatory requirements
Must have significant knowledge base in regulatory requirements by ensuring compliance to ICH E-6 Guideline for Good Clinical Practice in clinical, medical and regulatory activities
Oversees the development, implementation, and monitoring duties of the The Joint Commission Task Force
Serves as a member of the EOC Committee, Emergency Management Committee, Evidence Based Practice Committee, The Joint Commission Task Force Committee, Infection Control Committee, Quality Improvement Committee, Corporate Clinical Accountabilities Committee, The Clinical Pillar and Leadership Council
Reports to the Board of Directors performance improvement initiatives, publicly reported indicators
Works with departments and services to keep administrative policies and procedures current and uploaded to the intranet
Encourages and assists departments and services in the development of department specific regulatory policies and reviews them as needed or requested
Coordinates, monitors, and directs the hospital to achieve Joint Commission compliance through rounding and direct observation
Functions as the Joint Commission Task Force Chairperson and primary survey liaison
Clinical Quality Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Quality Manager
List any licenses or certifications required by the position: FEMA, CPC, RN, CDN, CNN, PMP, ASQ, CPHQ, ASCP, CCRP
Education for Clinical Quality Manager
Typically a job would require a certain level of education.
Employers hiring for the clinical quality manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Nursing, Education, Healthcare, Health Care, Public Health, Medical, Business, Health, Management, Life Sciences
Skills for Clinical Quality Manager
Desired skills for clinical quality manager include:
Managed care requirements related to clinical quality
CMS STARs
Regulatory requirements
Accreditation standards desired
Available internal resources
FMS clinical and administrative policies and procedures
Principles and practices to perform tasks and duties
Project management practices
Value Based Payer Programs
Medicare
Desired experience for clinical quality manager includes:
Identifies variances and recommends processes that ensure hospital Joint Commission compliance
Delegates assignments and maintains accountabilities to achieve and maintain Joint Commission compliance
Manages information and maintains an appropriate record of those activities relevant to survey preparation
Regularly appraises Administration of survey readiness
Reports, as needed, readiness status to the appropriate function chairs and management team members
Maintains current knowledge of the Joint Commission standards and applicable regulatory issues
Clinical Quality Manager Examples
1
Clinical Quality Manager Job Description
Job Description Example
Our innovative and growing company is looking for a clinical quality manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical quality manager
- Develops a culture of continuous survey readiness
- Works as mentor and facilitator of lean and lean/six sigma improvement efforts throughout the hospital
- There is frequent contact with Administration, management team members, physicians and other hospital personnel
- Position works in an office and throughout the hospital to insure that standards and regulatory compliance are being met
- Requires proficiency in Windows based software including Microsoft Word, Outlook, Excel, Access, and PowerPoint
- A bachelor’s degree and a minimum of 5 years experience in health care environment, or 10 years equivalent experience in healthcare required
- A Florida licensed healthcare provider is preferred ie
- Certification as a Professional in Healthcare Quality (CPHQ), LEAN and Six Sigma training strongly desired
- The Joint Commission preparation, Quality Management or related field, in a leadership role preferred
- Conduct quality audits of investigator sites and various clinical vendors
Qualifications for clinical quality manager
- Experience in the pharmaceutical industry with a strong understanding of clinical development
- Ability to work effectively in a fast-paced environment with effective organization and prioritization of work assignments
- Ability to deal with ambiguity, creative and pragmatic approach to problem solving
- Computer system validation (CSV) knowledge is a plus
- Proficient with computers and typical office software (e.g., Microsoft Office products)
- Minimum of 8 years experience in biopharmaceutical/pharmaceutical or related industry
2
Clinical Quality Manager Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of clinical quality manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical quality manager
- Conduct quality reviews or audits of clinical study documents, which include investigator brochures, clinical protocols/amendments, clinical study reports, case report forms and informed consents forms
- Conduct internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards and guidelines
- Provide expert CQA advice to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, ) based on analysis and interpretation of GCP regulations
- Conduct targeted training of investigators/site staff when required
- Report GCP related deficiencies to QA management, plans for corrective and/or preventive actions (CAPA)
- Assist clinical study teams in the development of CAPAs
- Assist with regulatory agency inspections
- Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products
- Understand the phases, processes and techniques used to execute a Quality Assurance Plan
- Provide Administrative Support, such as maintain audit logs, update checklists, templates, , as required
Qualifications for clinical quality manager
- Position requires a highly diplomatic, tactful and detail-oriented individual with exceptional critical reasoning skills
- Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
- Ability to deal with ambiguity, and develop creative and pragmatic solutions to GCP compliance risk areas
- Ideal candidate may work remotely but will be expected to travel 30-40% of the time
- RQA-GCP certification is a plus
- Bachelor's degree in the Life Sciences and a minimum 3 years of experience in supporting clinical operations for the Senior Associate level
3
Clinical Quality Manager Job Description
Job Description Example
Our company is searching for experienced candidates for the position of clinical quality manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical quality manager
- Thorough understanding of clinical practices
- Ability to anticipate, influence, and determine present and future business needs in support of quality for a program
- Leverages knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities
- Leads the effort to articulate and present an integrated cross-functional and comprehensive quality strategy plan
- Provides project/program leadership in quality as a team member across clinical development functions that impact the business
- Identifies and implements balanced fit-for-purpose quality management
- Comprehensive knowledge of the interrelationship among other RDQA GXP functions and with business functions to serve as a good business partner
- Develops and recommends strategies and tactics for success
- Identifies and removes barriers that could impact program objectives, priorities, timelines, and quality
- Primary program quality liaison during health authority inspections
Qualifications for clinical quality manager
- Solid understanding of ICH/FDA GCP guidelines essential
- Understand clinical development processes, and FDA inspection procedures
- Exposure to FDA regulated activities.also required
- Bachelor degree preferred or related work experience
- Knowledge of other Regulatory Authorities regulations are a plus
- Bachelor's degree preferably in a medical, scientific or technical discipline
4
Clinical Quality Manager Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of clinical quality manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical quality manager
- Facilitate and incorporate lessons learned, best practices
- Assists with analyzing and trends data related to complaint management performance, patient satisfaction
- Completes medical record reviews, including data collection, content review, and reporting
- Partners with internal cross-functional areas, such as Technical Manufacturing Services, Global Clinical Supplies, and Regulatory Affairs to manage a best in class GMP Quality Assurance program by strengthening the organization’s operational excellence in support of continued growth
- Acts as QA Operations management lead support for Product Development, New Product Introduction, and Tech Transfer activities for clinical product
- Provides quality oversight of CMOs including maintaining Quality Agreements, Quarterly Quality Reviews, Risk Management, decision-making during packaging operations and distribution activities, and on-site support as needed
- Develops and maintains necessary Standard Operating Procedures (SOPs) and Key Performance Indicators (KPIs) to manage internal processes and CMOs for all API and Drug Product manufacturing activities, applies Right-First-Time (RFT) initiatives, increases efficiency, mitigates risks and realizes expected quality and supply outcomes
- Supports review of GMP API and Drug Product contract manufacturing, testing, and shipping batch records and performs final quality decision for lot disposition to certify compliance with specifications and procedures and ensures product is delivered on time of supply need
- Provides support for requests from Qualified Persons to ensure release of product, including post-disposition notifications
- Ensures change controls related to all external API and Drug Product manufacturing activities for clinical product are authorized in accordance with procedures, works cross-functionally to ensure effective implementation against regulatory approval requirements and project timelines, and performs final quality decision for making the change effective and closure
Qualifications for clinical quality manager
- 2+ years of direct regulatory operational experience
- 1+ year of GCP document control knowledge or experience
- Proficiency with eCTD, Adobe Acrobat, and MS Office software including Outlook, Word, Excel, and PowerPoint
- Through knowledge of CTD/eCTD format and regulatory submission requirements
- Recent experience with IND, NDA, MAA, and other CTD submissions
- Knowledge of clinical development processes and guidelines
5
Clinical Quality Manager Job Description
Job Description Example
Our company is growing rapidly and is looking for a clinical quality manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical quality manager
- Takes a lead role to support operational unit in issue / deviations investigation of quality events detected during monitoring and data management, to identify root causes and corrective actions
- Oversee and manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams and maintain metrics
- Understand CTO operations and interpret processes to identify deviations or major risks to data integrity
- Lead efforts, authorize and manage submissions to internal and external agencies
- Oversee, develop and facilitate educational and compliance training programs
- Evaluate and analyze the impact on new regulations and determine how to implement within unit
- Serve as a regulatory point of contact during audits
- Interact and advise senior management on clinical trials regulatory processes or decisions
- Assists with the development, implementation and maintenance of CTO inspection preparation strategies and inspection readiness
- Assist in all other QA duties necessary
Qualifications for clinical quality manager
- Advanced scientific degree work
- Ability to set challenging goals, optimize resources, take initiative and achieve results
- Ability to travel nationally and internationally as business necessitates
- Lead the management of GCP quality activities in the support of studies and projects across clinical programs with a focus to drive proactive quality management within the clinical teams and across R&D as appropriate
- Point person to determine issues, potential risks and mitigation activities along with project management of timelines and deliverables for the RDQA Comprehensive Quality Strategy plan
- Assess the ongoing state of regulatory preparedness and assure inspection readiness by developing an audit program, applicable assessments, and other surveillance efforts of internal and external teams and vendors associated with a given program