(CW) Project Coordinator Data Science

BioMarin Pharmaceutical Inc. • San Rafael, CA

7d

About The Position

BioMarin Data Science is responsible for designing, capturing, analyzing, and presenting data that can drive key decisions for Clinical Development, Medical Affairs, and other business areas of BioMarin. With a quality-by-design culture, Data Science builds quality data that is fit-for-purpose to support statistically sound investigation of critical scientific questions. The Data Science team develops solid analytics that are visually relevant and impactful in supporting key data-driven decisions across BioMarin. The Data Management Science (DMS) group contributes to Data Science by providing complete, correct, and consistent analyzable data at data, data structure and documentation levels following international standards and GCP. The DMS Operations sub-function is responsible for the efficient and effective delivery of complete, correct, and consistently fit-for-purpose datasets for statistical analysis across all clinical development and post-approval programs. The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of all program-related data management activities such as protocol review, Case Report Form (eCRF) development, Data Management, development, Data Validation Plan development, requirement specifications, reconciliations, and data quality validation activities 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. The Project Coordinator may lead Study timelines discussions and be responsible for organizing meetings, generating meeting agendas and meeting minutes, and provide administrative support within the Global Data Science and Data Management Science groups. The Project Coordinator may also act as Executive Travel Coordinator, Process Improvement Initiative contributor, as needed. GDS Project Coordinator may perform a range of the following responsibilities, depending upon the studies’ complexity and studies’ development stage:

Requirements

• High school diploma required.
• Concise, strong communication, verbal and written skills
• Excellent organizational skills

Nice To Haves

• Preferred BA/BS degree with a focus in data science, statistics, computer science, life science, or related scientific discipline
• MS Project, MS Office Suite (Word, PowerPoint, Excel) experience preferred

Responsibilities

• 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 all documentation adheres to these standards.
• Documentation management: Organize, maintain, and archive electronic and physical documentation in compliance with company procedures and regulatory requirements.
• Expense Reports + Travel Planning/Scheduling: Organize, complete, follow up on expense reports and Executive travel planning and scheduling.
• Study Timelines: Generation and maintenance of GDS Study timelines with GDS and cross functional teams in MS Project Plan.

What This Job Offers

• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees