Company:
Pharmiweb
Location: Belfast
Closing Date: 04/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Clinical Trial Manager 60,000 - £67,000 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!
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