Job Description

Study Manager, Global Study Operations

Location: San Rafael, CA

12-Month Assignment

Pay Rate: $65/hr.

On behalf of our client a leading pharmaceutical company dedicated to developing therapeutics for patients with life threatening rare genetic diseases. We are seeking an experienced Study Manager to join the Global Study Operations team. The right candidate will be responsible for leading the operational execution of clinical studies across various phases.

Key Responsibilities

• Provide end-to-end oversight of clinical study execution across all phases of the study lifecycle (start-up, enrollment, maintenance, close-out).
• Lead cross-functional Study Execution Team meetings, driving alignment on timelines, risks, and deliverables.
• Monitor and manage study performance metrics, trends, and risks; implement mitigation strategies as needed.
• Collaborate with cross-functional partners (e.g., clinical development, data management, regulatory, safety) to ensure seamless execution of study plans.
• Support team development in partnership with People and Process Managers to promote productivity and career growth.
• Oversee day-to-day management of CROs and external vendors, ensuring deliverables are met on time and within budget.
• Manage study budgets and ensure accurate forecasting, tracking, and reporting.
• Coordinate the investigational product supply process, ensuring appropriate oversight and tracking.
• Contribute to the development and review of study documents including protocols, informed consent forms (ICFs), and operational plans.
• Ensure studies are conducted in accordance with GCP, regulatory requirements, and internal SOPs.
• Oversee study quality and data integrity, driving inspection readiness throughout the study.

Qualifications and Education:

• Bachelor’s degree (BA/BS/BSc) in a life sciences or medically related field, and 5+ years of relevant industry experience, including at least 3+ years in clinical research within a biotech, pharmaceutical, or CRO setting.
• In-depth understanding of clinical trial operations across all phases (Phase 1 through post-approval)
• Strong knowledge of GCP, ICH guidelines, and regulatory compliance.
• Experience with study budgeting, vendor management, and IP oversight.
• Experience working on global studies.
• Therapeutic area knowledge and product familiarity.

Please submit a copy of your resume In Word or PDF format to be considered.

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