Senior Clinical Study Manager (CSM)

Job Title: Senior Clinical Study Manager (CSM)
Location: 100% Remote
Type: Contract - 6 months with desire to go permanent
Compensation: $60.00 - $80.00
Work Model: Remote – offsite

Joule is current looking to hire aSenior Clinical Study Manager (CSM) to support clinical programs focused on cell/gene therapy and oncology for one of our clients. This is a remote, 40-hour/week contract (initial ~6 months) with the potential to renew or convert to full-time based on project need, performance, and budget. In this role, you will lead day-to-day study execution by partnering with CROs, sites, and cross-functional stakeholders while ensuring compliance with ICH-GCP and FDA requirements. The ideal candidate brings 8–10 years of clinical operations experience (including 4–5+ years in study management within pharma/biotech) and is comfortable managing timelines, budgets, vendors, and TMF oversight in a fast-paced environment.

Responsibilities

• Manage and oversee clinical study activities to ensure compliance with GCP, ICH, and FDA regulations
• Coordinate with CROs, vendors, and site teams to ensure timely progress of clinical trials
• Prepare and review study documentation, reports, and progress updates
• Handle budgets, contracts, and invoices related to clinical studies
• Ensure TMF management and oversight in accordance with regulatory standards
• Monitor site activities and ensure site management best practices

Requirements

• University/college degree (BS/BA/MS) or certification in a related health profession from an appropriately accredited institution
• 8 – 10 years’ experience, including 4 – 5 years of experience in a pharmaceutical setting
• Previous study management experience with at least 4 – 5 years of relevant experience
• Experience in Cell/Gene Therapy and Rare diseases; recent Oncology experience is desirable

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical