Senior Study Operations Specialist

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients.

About Research and Development: From research and discovery to post-marketing 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 breakthrough medicines that provide meaningful advances to patients living with rare genetic conditions.

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:

• Core 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, POs, and invoice management (e.g., CROs, central labs, imaging 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.

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.