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US-Nationwide, Manager Clinical Quality Assurance |
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Job Category:
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Quality Affairs/Assurance |
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Job description:
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Outstanding career opportunity for a successful Manager Clinical Quality Assurance located in PA.
Manage the Clinical Quality Assurance group to assure that processes, procedures and activities are in compliance with GCPs and other prevailing regulations and guidances.
Conduct and/or supervise audits of internal processes/ procedures, clinical investigators, clinical databases, study reports, contract CROs/labs, and IRBs in order to assess the accuracy and quality of scientific data
Train and mentor junior auditors
Assist in the development and maintenance of CQA SOPs and audit tools
Investigate and resolve compliance problems and questions regarding Clinical Regulatory Affairs, Clinical Operations, Data Management and Biostatistics
Host and/or facilitate regulatory agency inspections
Provide CQA support for regulatory filings
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Skills:
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MS/BS degree in Scientific Discipline/ Life Sciences
2+ years of supervisory experience
5+ years experience in Clinical Quality Assurance and/or other relevant GCP experience
Thorough knowledge of Federal and other applicable regulations, Good Clinical Practices (GCPs), quality systems (SOPs) and audit procedures and reporting.
Capable of planning activities to meet CQA objectives
Ability to resolve and document quality problems as appropriate and know when to elevate problems to a higher level
Experience applying principals of 21 CFR Part 11 to clinical systems
Capable of writing effective SOPs, Quality Assurance Reports and training materials
Ability to multi-task; to develop systems and SOPs while reviewing protocols and reports
Excellent communication skills - both written and verbal
Strong computer skills - MS Office
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Employment type:
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Salary Range:
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Unspecified |
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Degree:
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Bachelors |
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Experience (year):
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2 |
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Job Location:
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Nationwide - CO - USA |
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Post Date:
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11/17/2008 |
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