Parexel
10,000+ employees
Founded 1983
âď¸ Healthcare Insurance
𧏠Biotechnology
đ Pharmaceuticals
đ° Venture Round on 1990-01
Healthcare Insurance ⢠Biotechnology ⢠Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
Senior Clinical Research Associate
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Parexel
10,000+ employees
Founded 1983
âď¸ Healthcare Insurance
𧏠Biotechnology
đ Pharmaceuticals
đ° Venture Round on 1990-01
Healthcare Insurance ⢠Biotechnology ⢠Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
đ Description
⢠Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices. ⢠Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met. ⢠Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites. ⢠Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution. ⢠Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable
đŻ Requirements
⢠Bachelorâs degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent ⢠Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations ⢠Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology)
đď¸ Benefits
⢠Health insurance ⢠Retirement plans ⢠Professional development opportunities
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