(CW) Sr. Study Specialist

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research And Development

From research and discovery to post-market clinical development, our R&D 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 rare diseases.

CONTRACT Hybrid on Tues. and Thurs. in San Rafael or remote based employee within the US. ***

Sr. Study Specialist

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 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

Core Competencies

The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:

• .Agility and Proactivity
• .Leadership
• .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 study specific documentation, as delegated by the Study Manager
• .Contribute to the oversight of country and site feasibility assessment and site selection.
• .Oversight of CRO for IRB/EC related submission/approval activities
• .Oversight of essential documents for study life-cycle management
• .Develop/Oversee site and investigator training materials
• .Present at investigator meetings as assigned
• .Ensure accurate and timely study entry and updates to ClinicalTrials.gov
• .Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
• .Process documents for signature in DocuSign
• .Oversight of Clinical Trial Insurance
• .Attend Global Study Operations team, vendor, 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
  
  
  

Education & Experience

• .BA/BS or higher in nursing, life or health sciences is preferred.. Industry or relevant experience in lieu of education is considered.
• .Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets,
  
  
  

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.