Industry: Pharmaceuticals
Title: Sr. Study Specialist, Global Study Operations
Location: San Rafael, CA (Hybrid: 3 days/wk remote)
Duration: 12 months contract (+Chances of extension)
Overview :
The Client 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.
Client 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. Client aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative Client therapeutics, advancing the standard of care, and providing personalized support and services globally.
Role Summary
Core Competencies:
Technical Competencies:
Responsibilities include but are not limited to:
Skills :
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.)
Education :
BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
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