Sr. Director of Data Quality ScienceLocation San Rafael, California
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Data Quality Scientist is a data scientist who specializes in the conceptualization, design, development, implementation, and evaluation of data flow, workflow and information systems for clinical trial research. The Director/Senior Director of DQS must be an expert in the clinical data lifecycle in clinical research settings and will be responsible for designing, reporting and conducting the data quality management of clinical research studies. S/He will apply knowledge of data science, data structures, computer programming, quality management, research design, and applicable regulations to accomplish common job responsibilities including database design specification, development and validation of clinical databases and integration of external data. This role also serves as a database design consultant to investigators and clinicians designing and conducting clinical studies by working as a member of the clinical study team and as one of multiple individuals providing support to clinical research projects.
Responsibilities and Duties
The Director/Senior Director DQS will:
- Recruit and manage staff for the new DQS group in collaboration with the Executive Director Clinical Data Management.
- Oversee the work of members of the DQS team performing system testing and provide timely feedback with respect to quality and productivity.
- Partner with internal and external teams to develop and implement new processes and technologies to improve Clinical Data Management efficiencies.
- Support the development of study databases according to defined timelines and specifications.
- Work across the group to coordinate resources across multiple studies.
- Select, develop, implement, and manage standard controlled terminologies and other data standards in collaboration with cross-functional governance to ensure the use of standard processes across the entire data lifecycle from protocol to database archival.
- Draft and maintain up-to-date and accurate standard and technology documentation including functional specifications for database systems.
- Design and manage functional and user acceptance testing for systems and system interfaces
- Design and execute control functions within the Quality Management System (QMS) to assure compliance with applicable regulations and SOPs.
- Design data and workflow for large or complex studies.
- Draft access control procedures for programs.
- Design standards and technology training for clinical research study teams.
- Specify and evaluate data system functionality.
- Write and manage system validation plans and change controls.
- Coordinate and control data standards and technology usage for complex studies.
Experience Knowledge and Skills
The Director/Sr. Director of DQS requires a master’s degree in a related field, with a minimum of eight years of experience directly related to clinical research data management/quality. A doctorate degree in information, clinical or health-related sciences is preferred.
The candidate must possess expertise in the clinical data lifecycle in a research setting. It is also important that the candidate possess knowledge of applicable regulations and clinical research operational processes, such as human subject protection, production of research results, and data sharing.
The DQS Director/Sr. Director must be able to apply this knowledge to successfully acquire and manage data from any source, and coach and work with others in a team-based setting to maintain process and cost effective data processes for clinical research.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.