Study Start Up Lead

Job Title: Study Start Up Lead
Location: South San Francisco, CA
Type: Contract
Compensation: $80 - $88/hour
Contractor Work Model: Onsite
Hours: 40.0

Overview
The Study Start Up Lead will lead country-level study start-up strategy and execution to activate sites efficiently and compliantly for client-sponsored clinical trials. This role partners with global teams, country stakeholders, sites, and CROs to manage key start-up deliverables including regulatory/ethics submissions and amendments, ICF oversight, site documentation readiness, and budget/contract/payment coordination.


Responsibilities

• Lead the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Oversee start-up operations ensuring timely site activation and regulatory compliance.
• Develop and oversee clinical trial submissions, amendments, and coordination with regulatory agencies.
• Manage site documentation and compliance, including translation and approval of drug labels and patient-facing materials.
• Strategically plan and oversee budgeting, contracts, and payments related to clinical trial start-up activities.
• Collaborate with global and regional teams to harmonize systems and improve start-up timelines.
• Engage with government and institutional bodies to align clinical trial policies and practices.

Requirements

• Bachelor's degree in life sciences or equivalent; postgraduate degree highly desirable.
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• Experience managing vendor/CRO relationships.
• Excellent communication and interpersonal skills.
• Strong organizational, analytical, and problem-solving capabilities.
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.).
• Fluent in written and spoken English.

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