Senior Study Operations Specialist

Responsibilities

• Lead tasks related to site monitoring oversight, vendor management, and clinical study operations.
• Develop study-specific documentation and oversee site and investigator training materials.
• Contribute to country and site feasibility assessments and site selection processes.
• Oversee CRO activities regarding IRB/EC submissions and approvals.
• Manage essential documents throughout the study life-cycle and oversee the Trial Master File (TMF).
• Manage external vendor relationships, including oversight of SOW, budgets, POs, and invoice management.
• Ensure accurate and timely study updates to ClinicalTrials.gov.
• Identify and contribute to Global Study Operations risk mitigation strategies.
• Represent Global Study Operations in vendor and cross-functional study execution meetings.

Requirements

• BA/BS in nursing, life sciences, or health sciences (preferred), though relevant industry experience may be considered in lieu of a degree.
• Proven experience in the biotechnology or pharmaceutical industry.
• Experience with vendor oversight, including CROs, central labs, and imaging providers.
• Proficiency in managing SOWs, budgets, purchase orders, and invoices.
• Hands-on experience with Trial Master File (TMF) management.

About the Company

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, BioMarin uses a distinctive approach to drug discovery and development to pursue category-defining medicines that have a profound impact on patients.