Clinical Trial Manager

Job Title: Clinical Study Manager

Location: England, UK

Company: Biotech

About Us:

Our partner is a pioneering cell and gene therapy biotechnology company dedicated to developing transformative treatments for patients with rare and life-threatening conditions. Our mission is to bring cutting-edge therapies from the bench to the bedside, improving lives and redefining healthcare through innovation and collaboration.

Role Summary:

They are seeking an experienced Clinical Study Manager (CSM) to oversee and drive the execution of clinical trials for our innovative cell and gene therapy programs. The successful candidate will play a pivotal role in managing clinical studies, ensuring they are conducted with the highest standards of quality, ethics, and regulatory compliance.

Key Responsibilities:

Study Planning & Execution:

• Lead the planning, initiation, and execution of Phase I-IV clinical trials, ensuring alignment with project timelines and deliverables.
• Develop and manage study-specific plans, including budgets, timelines, and resources.
• Oversee vendor selection and management (e.g., CROs, central labs) to ensure study quality and adherence to contractual agreements.

Team Leadership:

• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, quality assurance, and medical affairs, to drive study success.
• Lead study-specific meetings, ensuring effective communication and issue resolution.

Regulatory Compliance:

• Ensure studies comply with applicable regulatory guidelines, including ICH-GCP, MHRA, and EMA regulations.
• Prepare and manage essential study documents, such as investigator brochures, clinical study protocols, and clinical trial applications (CTAs).

Patient Recruitment & Site Management:

• Develop strategies to optimize patient recruitment and retention in alignment with study objectives.
• Establish and maintain strong relationships with investigators, site staff, and key stakeholders.

Data Management & Reporting:

• Oversee data collection, monitoring, and reporting processes to ensure data integrity and accuracy.
• Provide regular updates to senior management on study progress, milestones, and risks.

Requirements:

• Bachelor's degree in life sciences, pharmacy, or related field (advanced degree preferred).
• Proven experience as a Clinical Study Manager in the biotech or pharmaceutical industry, ideally with expertise in cell and gene therapy trials.
• Comprehensive knowledge of clinical trial processes, including protocol development, site management, and regulatory submissions.
• Strong understanding of ICH-GCP guidelines and European regulatory requirements.
• Excellent organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.

Why Join Us?

• Opportunity to work at the forefront of cell and gene therapy innovation.
• Be part of a collaborative and dynamic team dedicated to improving patient outcomes.
• Competitive salary and benefits package, including opportunities for career growth and development.