Study Specialist Ii, Global Study Operations

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.

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.

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**

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.)

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.

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.