Study Specialist II

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

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Description

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.

Job Description

Job Description

Hybrid SRC 2 days/wk or Remote if >100 miles from SRC  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 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 organization is tasked with providing strategic direction on the feasibility, design, and conduct of Phase 1-4 and post approval studies and drives the delivery of high-quality data to support the registration approval and post approval activities of our clinical development assets. The organization 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 II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies:
Core Competencies:
●     Agility and Proactivity
●     Communication and Collaboration
Technical competencies:
●     Study Management and Execution
●     Compliance and Quality
●     Drug Development and Study Design
●     Product and Therapeutic Area Knowledge

Responsibilities include but are not limited to:
●     Develop and/or review study specific documentation, as delegated by the Study Manager 
●     Contribute to the management of country and site feasibility assessment 
●     Provide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sites 
●     Contribute to the collection and oversight of essential documents for study life-cycle management
●     Contribute to the development of site and investigator training materials 
●     May present at investigator meetings as assigned 
●     Ensure timely study entry and updates to ClinicalTrials.gov 
●     Ensure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor) 
●     Provide administrative assistance with internal and external meetings including investigator meeting(s) as warranted
●     Facilitate Screening Authorization Forms tracking/sign off where applicable 
●     Manage various Global Study Operations document translations as applicable
●     Process documents for signature in DocuSign 
●     Site management for delegated site(s)
●     Manage and resolve site related issues and risks escalated to BioMarin that can’t be resolved by CRO.​
●     Contribute to identifying risks identification and mitigations
●     Oversee the Clinical Trial Insurance process
●     Support Study Manager to ensure timely delivery and handling of IP to the sites 
●     Support Vendor Management
●     Attend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested. 
●     Oversee and manage essential documents in the Trial Master File (TMF) 
●     Contribute to Global Study Operations risks identification and mitigations. 
●     Provide support and administrative assistance with internal and external meetings
●     Assist with filing GSO internal study documents in internal systems
 
  
Education & Experience
●     BS or higher in nursing, life or health sciences is preferred  
◦     Industry or relevant experience in lieu of education may be considered
●     Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.) 




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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