Senior Gene Therapy Clinical Operations Manager
4 weeks ago
Gene Therapy Clinical Study Manager Opportunity
- Lead Groundbreaking Gene Therapy Studies: As a key member of the S3 Science team, you will oversee clinical operations for gene therapy studies, ensuring compliance with ICH/GCP guidelines and delivering high-quality results on time and within budget.
- Drive Site Management for Innovative Gene Therapy Trials: From initiation and feasibility to closeout, you will handle site selection, budget negotiation, trial agreements, and day-to-day communication.
- Collaborate with Data Teams for Timely and Accurate Reporting: Work closely with data teams and external vendors to ensure timely and accurate data reporting, and manage outsourced vendors and assess their performance.
- Ensure Regulatory Excellence: Prepare and submit clinical trial applications for UK HRA approval and support processes in the US, always keeping studies audit-ready.
- Contribute to Process Optimization: Play an integral role in process optimization, recommending and implementing improvements in resources, tools, and procedures.
- Experience: A background in clinical trial management with 2+ years in a commercial setting or 4+ years as a Clinical Research Associate.
- Education: A degree in Biological Sciences or equivalent.
- Compliance Knowledge: In-depth understanding of MHRA, FDA, EU, and ICH GCP regulatory frameworks.
This is an exciting opportunity to be part of a mission-driven team making strides in gene therapy and enjoy a role where your expertise drives clinical innovation.
We are looking for a Clinical Trial Manager with a passion for making a real impact in gene therapy and a desire to work on groundbreaking projects.
S3 Science is a company that values science and innovation, and we are committed to shaping the future of gene therapy together.
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