Clinical Quality Assurance – GCP Specialist
Job Description: • Support GCP compliance for clinical operations to ensure regulatory adherence. • Assist in compliance processes and collaborate with cross functional teams to maintain clinical trial integrity. Requirements: • Bachelor’s degree in a scientific or related discipline, or 5 years of equivalent experience. • 3-5 years of eTMF experience, including study start-up, maintenance, and quality reviews. • 3+ years of experience in pharmaceutical industry roles related to clinical trials (e.g., clinical operations, project management). • Experience in quality assurance or quality management activities. GCP Specialist • Experience with GCP vendor and site audits preferred. • Ability to manage projects and tasks in a fast-paced environment. • Analytical and critical thinking skills for quality review decision-making. • Knowledge of pharmaceutical industry standards, including ICH/GCP guidelines. • Experience with BIMO inspections preferred; EMA/MHRA/PDMA experience a plus. • Communication skills, both verbal and written. • * Leadership and problem-solving skills. • Ability to translate strategy into operations and manage multiple priorities. • Ability to work independently with limited supervision. Benefits:Apply Now
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