Clinical Quality Manager Cover Letter

I am excited to be applying for the position of clinical quality manager. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for clinical pharmacology sections related to drug-drug interactions or basic pharmacokinetic principles and regulatory responses based on internal customer needs and to fulfill regulatory requirements.

Please consider my qualifications and experience:

• A minimum of a BS preferably in chemistry or life sciences
• A pharmacy, nursing and/or healthcare background is preferred
• Experience conducting and reporting on PV, GCP, GLP quality audits and CAPA
• Experience with developmental and commercial adverse event reporting requirements
• Proven success in leading large global complex projects
• Demonstrated experience in implementation of project management methodologies in a global clinical research environment
• Proven success in leading projects independently and providing strategy and approach for addressing needs of the project and business objectives
• Comprehensive understanding of quality management as applied in clinical research

Please consider me for the clinical quality manager opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for leadership and direction to the Cardiology ambulatory practices and hospital based programs regarding efficient care delivery models, staffing analyses, performance improvement, clinical and administrative systems enhancements, regulatory requirements, revenue cycle management, patient satisfaction, and provider engagement.

My experience is an excellent fit for the list of requirements in this job:

• Previous experience of Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance is preferred
• Extensive knowledge of global, regional and national regulatory requirements and regulations
• Have a demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies
• Have demonstrated project management skills and management of cross-functional activities
• Effectively document assessment findings in an assessment report and obtain responses in a timely fashion
• Report and present to clinical development staff, clinical investigators and contract research organization staff findings from assessments and give advice on resolving issues identified
• Partner with CQA Management to develop, implement and assess clinical quality assurance strategies, organizational and operational needs
• Act as a consultant and represent department to clinical development staff and teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment

I am excited to be applying for the position of clinical quality manager. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for expertise to review and address changes to global regulatory requirements and industry best practices and facilitate implementation through new or revised internal clinical procedures and/or processes.

My experience is an excellent fit for the list of requirements in this job:

• Able to lead and people manage in the absence of the Head of QM Operations
• Excellent communication skills via all methods face to face, phone, email, teleconference, video conference
• Advanced skills in computer applications, such as Word, Excel, and Power Point
• Experience with respect to finished product packaging and distribution for clinical supplies used in phase I through phase IV clinical trials commercial product
• Experience in computerized system lifecycle management and the application of industry best practices
• Experience in participating in regulatory inspections, presenting/defending IT functions in audits or regulatory inspections will be an advantage
• In depth understanding of GCP and global regulations and standards that govern the development of clinical products (CFR, ICH, EU Directives, as examples)
• GCP and regulatory clinical trial process and phase expertise, including operational specialty areas like pregnancy and pediatrics

I submit this application to express my sincere interest in the clinical quality manager position.

In the previous role, I was responsible for leadership and management for cross-regional initiatives to drive reductions in clinical practices variations and standardize successful clinical practices.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Deep knowledge in quality regulation requirements covering GLP, GSP, GXP and general quality compliance
• Good knowledge of animal testing
• Experience with respect to finished product packaging and distribution product packaging and distribution for clinical supplies used in phase I through phase IV clinical trials
• Experience in clinical operations and handling trial essential documents ispreferred
• Strong knowledge of global regulatory requirements for clinical trials and ICH/GCP/GLP guidelines
• Auditor, Lead Auditor, and ISO Lead Assessor training preferred
• Knowledgeable in Clinical Trial regulations domestic and international including
• A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance

I submit this application to express my sincere interest in the clinical quality manager position.

In my previous role, I was responsible for consultation to Optum management and staff regarding such issues as clinical standards, policies, procedures, recovery and resiliency and best practices.

My experience is an excellent fit for the list of requirements in this job:

• Support the recruitment of new CQA staff
• Manage/Champion and participate in other projects or duties assigned by the CQA management specific to CQA teams accountabilities
• Certified IRB or Clinical Research Professional (CRP)
• Experience working with health care quality measurement data such as NCQA HEDIS, New State QARR, CMS Star program data
• Medical record review experience directly working on HEDIS/QARR
• NYS LPN, RN, LMSW or LCSW
• Demonstrated excellent collaborative and interpersonal skills
• Advanced knowledge and experience with computer applications, including word processing, spreadsheets, and database applications data analysis skills