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POSITION SUMMARY:
The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency regulations and standards, GCP, industry guidelines, and Apnimed policies and procedures for the conduct of clinical studies.
The position will utilize audit and inspection intelligence, SOP development, training and risk mitigation plans to assure adherence to GCP/GPV requirements in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients. The position is accountable for the execution of Quality Assurance (QA) audit activities on assigned studies/products/vendors and preparation of the organization for BIMO inspection. This role is responsible for Good Clinical Practice (GCP) and Pharmacovigilance (GPV) oversight, and for assessing the compliance of studies with Apnimed Standard Operating Procedures, Policies, and all applicable worldwide regulations and guidelines (e.g., US FDA, EU Directives, ICH).
KEY RESPONSIBILITES:
QUALIFICATIONS:
Full Time
$128k-161k (estimate)
06/09/2024
07/03/2024
apnimed.com
Cambridge, VT
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