Clinical Study Lead
2 weeks ago
Company Overview: EPM Scientific is a global pharmaceutical group with a strong track record of innovation. We are seeking a highly motivated Clinical Study Lead to join our team in San Francisco.
Job Summary: As a Clinical Study Lead, you will be responsible for leading in-house study activities for a large global Phase 3 study. You will mentor junior team members, oversee the set-up and maintenance of study systems, and report to the Clinical Program Lead.
Key Responsibilities:
- Lead in-house study activities for a large global Phase 3 study
- Mentor junior team members to ensure their growth and development
- Oversee the set-up and maintenance of study systems, including Clinical Trial Management System (CTMS), Trial Master File (TMF), and study SharePoint
- Report to the Clinical Program Lead and provide regular updates on study progress
- May be responsible for CRA and CTAs as direct reports
Requirements:
- 5+ years of sponsor/CRO experience
- 3+ years of ON-SITE monitoring experience
- 2+ years of experience leading studies or trials in-house (rare disease or derm preferred)
- At least 2 years of experience managing direct reports or mentoring junior clin ops team members
- A Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or a related discipline
- A working knowledge of ICH GCP guidelines
What We Offer:
- Competitive salary with benefits
- High degree of commercial exposure early in your career
- Opportunity to work with a team that aims to improve the quality of people's lives
- Great work-life balance
How to Apply: If you are interested in this Clinical Study Lead role, please don't hesitate to reach out to us.
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