Job Description
Clinical Trial Manager / Senior Clinical Trial Manager
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San Diego, CA | Hybrid 3-Days Onsite
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We are partnering with a growing, clinical-stage biotechnology company focused on advancing innovative therapies in immunology. With a progressing clinical pipeline and continued organizational growth, the company is looking to add a Clinical Trial Manager to its team.
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This is a high-visibility opportunity for a Clinical Trial Manager who wants to take meaningful ownership of clinical programs while working closely with senior leadership, including the Chief Development Officer.
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The company has recently reached an exciting international development milestone with a global submission!
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Key Responsibilities
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- Lead the day-to-day operational management of clinical trials across an immunology portfolio
- Develop and maintain study timelines, operational plans, and key trial deliverables
- Partner closely with CROs and external vendors to ensure successful study execution
- Monitor study progress, identify risks, and develop mitigation strategies
- Support site selection, initiation, monitoring, and close-out activities
- Collaborate cross-functionally with Clinical Development, Medical Affairs, Data Management, Biostatistics, Regulatory, and other key stakeholders
- Review and oversee study documentation, metrics, and operational deliverables
- Support budget management and vendor oversight
- Ensure clinical trials are conducted in accordance with applicable regulations, protocols, and quality standards
- Communicate study status, risks, and key milestones to senior leadership
- Contribute to the continued development and optimization of Clinical Operations processes
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What We're Looking For
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- Bachelor's degree in Life Sciences, Nursing, or a related discipline; advanced degree preferred
- 5+ years of clinical research experience within the pharmaceutical, biotechnology, or CRO environment
- Previous experience managing clinical trials from study start-up through execution and/or close-out
- Strong experience working with CROs and external vendors
- Demonstrated ability to manage multiple priorities, timelines, and stakeholders
- Strong understanding of ICH-GCP and clinical trial regulations
- Excellent communication, organizational, and problem-solving skills
- Ability to operate effectively in a fast-paced, growing biotech environment
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Please apply for full job description and company details!