Sr. Clinical Trial Specialist

Location:  San Rafael, California Category: Clinical Employment Category: Fulltime-Temporary

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. 
 

Duties


*** Remote until onsite restricitons are lifted ***


 


The Sr. Clinical Trial Specialist (CTS) is a critical role at BioMarin, holding key responsibilities for the execution of the clinical trial and driving day-to-day activities to help the clinical operations team support study timelines, quality and budget.

Skills



    • Motivation and Organization.  Driven to meet commitments and deliver high quality work on time.  Perform assigned tasks independently, prioritize tasks with help from manager and study lead, delegate tasks appropriately, and escalate issues as necessary.  Facilitate meetings within and across functions, anticipate future risks, needs and workloads, and set suitable timelines.  Demonstrate initiative in all aspects.  

    • Teamwork and Communication.  Work closely with other members of the clinical operations team and proactively offer support wherever needed.  Prepare training materials and educate members of the study team.  Collaborate with cross-functional teams, adapt to changing timelines with composure, and exhibit enthusiasm to supply on-time deliverables and help the team meet corporate timelines.

    • Vendor Management.  Contribute to vendor evaluation and selection.  Hold regular meetings with vendor project managers and oversee day-to-day operations to ensure vendor performance to statement of work, especially delivery of critical milestones.  Review statements of work and initiate change orders as needed.  Verify accuracy of vendor invoices and monthly accruals.  Escalate issues when necessary.

    • Data Integrity.  Perform data review of study subjects to ensure data accuracy, completeness, and compliance with clinical protocol.  Apply keen attention to detail to verify data quality, and issue queries and protocol deviations as warranted.  Work with cross-functional team to resolve issues.

    • Clinical Site Management.  Oversee multiple clinical sites as sponsor representative, partnering closely with CRO to serve as resource and confirm site compliance with protocol.  Perform initiation, monitor oversight, and other site visits to assess CRO quality of work and ensure site staff are properly trained and supported.  Review trip reports to ensure that clinical sites are receiving adequate monitoring. 

    • Compliance.  Monitor compliance with GCP, SOPs, and other applicable regulations during the execution of the study.  Ensure essential documents from clinical team, sites, and vendors are maintained in trial master file.

Education



    • Education & Experience:


      • BA/BS or higher in nursing, life or health sciences is preferred.  Industry or relevant experience in lieu of education is considered.

    • 3 - 5 Years of Experience

 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.