Clinical Trials Compliance Specialist

2 days ago


erode, India beBeeCompliance Full time

Job Title: Clinical Quality Compliance ManagerClinical trials require meticulous attention to detail and adherence to established protocols. As a Clinical Quality Compliance Manager, you will play a pivotal role in ensuring the quality and integrity of clinical trial sites.Key responsibilities include:Conducting site audits to verify compliance with regulatory requirementsReviewing Case Report Forms (CRFs) and regulatory documents for accuracy and completenessIdentifying and reporting audit findings to ensure corrective actions are takenProviding guidance and training to site staff on compliance mattersSuccess in this role requires a deep understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and FDA/EMA regulations. Additionally, strong communication, analytical, and organisational skills are essential for effective collaboration with site staff and stakeholders.Minimum qualifications include a Bachelor's degree in life sciences, nursing, pharmacy, or a related field, along with 10-12 years of clinical research experience, preferably with auditing and QA experience.



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