Are you ready to take on a challenging and rewarding role that puts you at the forefront of clinical research?
We’re looking for a Clinical Trial Manager with a passion for making a real impact in gene therapy. This position offers the chance to shape and drive the successful execution of cutting-edge clinical studies, from start-up to closeout. If you’re experienced, ambitious, and eager to work on groundbreaking projects, this is the opportunity for you!
What You’ll Do:
Lead Clinical Studies: 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: From initiation and feasibility to closeout, you’ll handle site selection, budget negotiation, trial agreements, and day-to-day communication.
Data & Vendor Oversight: Work closely with data teams and external vendors to ensure timely and accurate data reporting. You’ll also manage outsourced vendors and assess performance.
Regulatory Excellence: Prepare and submit clinical trial applications for UK HRA approval and support processes in the US, always keeping studies audit-ready.
Continuous Improvement: Play an integral role in process optimization, recommending and implementing improvements in resources, tools, and procedures.
What We’re Looking For:
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.
Be part of a mission-driven team making strides in gene therapy and enjoy a role where your expertise drives clinical innovation.
This is your chance to step into a leadership role where science and innovation meet. Let’s shape the future of gene therapy together!