(CW) Project Coordinator Data Science
BioMarin Pharmaceutical Inc.About the role
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
The GDS Project Coordinator role focuses on ensuring the accuracy, completeness, and integrity of the clinical trial data and related documentation. This position combines knowledge of clinical research with strong data management, organization and documentation skills. The Project Coordinator is responsible for managing various types of documentation associated with clinical trials within the data science and data management science domains.
- Clinical documentation review: Conduct thorough reviews of clinical trial documentation, including protocols, consent forms, case report forms, and study reports, to ensure accuracy, completeness, and consistency with regulatory guidelines and internal standards.
- Data quality assurance: Collaborate with DMS Program Leads, DMS Study Leads and other team members to identify and resolve data discrepancies and ensure the overall quality and integrity of the clinical data.
- Regulatory compliance: Knowledge of relevant regulatory requirements (e.g., GCP, FDA guidelines) and ensure a
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