Study Specialist I, Global Study Operations - San Rafael, United States - BioMarin
Description
Who We Are
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.
THIS ROLE IS HYBRID AND REQUIRES WORKING IN SAN RAFAEL A MINIMUM OF 2 DAYS PER WEEK
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care, and providing personalized support and services globally.
The BioMarin Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets.
The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
Role Summary
The Study Specialist I (SS I) responsible to complete tasks related to the administrative support of study teams and department members and efforts.
Assignments may include contributing to or supporting teams as an ad-hoc or SWAT resource and in some cases may require line manager approval depending on level of effort and/or duration.
Activities and responsibilities may include:
- BOARD Quarterly MVR GSO Compliance and other metrics
- SRDO Program Roster updates and maintenance
- GSO Department Website maintenance
- Knowledge Manager; responsible for maintaining the department website, GSO Dept Teams locations, and reconciling/filing between Teams and the GSO SharePoint Content Center
- The below tasks may also be included when unsupported by study staff and/or CRO:
- eTMF and SharePoint/Teams documents; may include upload, correction, review, and reporting
- Clerical assistance to arrange internal/external meetings and teleconferences
- Process documents for DocuSign signatures (e.g., facilitate and/or support IP package review/signatures, ICF signatures)
- Assist with tracking and review of Clinical Trial Insurance requirements, expiry dates, insurance renewal, certificate distribution, and archival
Skills:
- Relevant administrative experience including detail oriented, collaborative, positive attitude, ability to prioritize, proactive, and good follow up skills,
- Proficient in MS Suite; Excel, Word, Outlook, Zoom, and Teams
Education:
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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