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 experiencedClinical 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.