CVS Health
Woonsocket, Rhode Island, United States
Quality Manager - Clinical Trial Operations
Posted over 1 month ago
Job Description
Job Description
The Quality Manager, Clinical Trial Operations will support trial and site-specific quality activities in the Clinical Trial Services Business Unit (CTS BU). The role provides mentoring and quality support to the trials team to ensure quality of deliverables and achievement of study goals. The role will support the tracking and reporting of performance and quality indicators and assisting in the development of Quality Tolerance Limits (risk thresholds). This role will provide support for audit and the preparation of Health Authority Inspections.
Required Qualifications
o 8+ years of experience in the pharmaceutical, biotechnology or related health care industry.
o 4+ years of relevant clinical trial experience
Preferred Qualifications
Working Knowledge Of:
* GCP regulations and industry best practices.
* Performance, Quality and Risk Indicators.
* Statistical tools
* Reporting and Analytics
* Health Authorities and inspection conduct
Skill In:
* Working at the Site level with staff
* Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
* Proactive approaches to identifying and addressing areas exposure
Ability To:
* Collaborate with teams
* Problem solving, conflict resolution and critical thinking skills
* Assess risks and impact
* Function with a high degree of autonomy, quickly adapt to changes in business priorities and effectively manage competing priorities.
Education
Bachelors Degree Required; Masters Preferred
Business Overview
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
The Quality Manager, Clinical Trial Operations will support trial and site-specific quality activities in the Clinical Trial Services Business Unit (CTS BU). The role provides mentoring and quality support to the trials team to ensure quality of deliverables and achievement of study goals. The role will support the tracking and reporting of performance and quality indicators and assisting in the development of Quality Tolerance Limits (risk thresholds). This role will provide support for audit and the preparation of Health Authority Inspections.
Required Qualifications
o 8+ years of experience in the pharmaceutical, biotechnology or related health care industry.
o 4+ years of relevant clinical trial experience
Preferred Qualifications
Working Knowledge Of:
* GCP regulations and industry best practices.
* Performance, Quality and Risk Indicators.
* Statistical tools
* Reporting and Analytics
* Health Authorities and inspection conduct
Skill In:
* Working at the Site level with staff
* Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
* Proactive approaches to identifying and addressing areas exposure
Ability To:
* Collaborate with teams
* Problem solving, conflict resolution and critical thinking skills
* Assess risks and impact
* Function with a high degree of autonomy, quickly adapt to changes in business priorities and effectively manage competing priorities.
Education
Bachelors Degree Required; Masters Preferred
Business Overview
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.
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