Clinical Trials Quality Manager

2 weeks ago

alappuzha, India beBeeAudit Full time

Quality Assurance AuditorThe Quality Assurance Auditor is responsible for ensuring compliance and quality at clinical trial sites. This includes conducting site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP, and regulatory requirements.Conduct audits of clinical research sites across phases I–IV.Review CRFs, informed consent forms, and regulatory documents.Identify and report audit findings; recommend corrective actions.Support site staff with compliance guidance and training.Prepare audit reports and follow up on CAPA implementation.Key Qualifications:Bachelor's degree in life sciences, nursing, pharmacy, or related field.10-12 years of clinical research experience, with auditing and QA experience.Knowledge of GCP, ICH guidelines, and FDA/EMA regulations.Strong communication, analytical, and organizational skills.Ability to travel is required.Preferred Skills:Clinical Research or Quality Auditing certification (ACRP, SOCRA).Experience with eTMF and EDC systems.Experience auditing multi-center or global trials.

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    alappuzha, India beBeeEDC Full time

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    alappuzha, India beBeeAudit Full time

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    alappuzha, India beBeeStatisticalProgramming Full time

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    alappuzha, India beBeeData Full time

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    alappuzha, India beBeeStatistician Full time

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