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- Tasks: Lead and manage clinical trials for groundbreaking cell and gene therapies.
- Company: Join a pioneering biotech company transforming healthcare for rare conditions.
- Benefits: Enjoy competitive salary, career growth, and a collaborative team environment.
- Why this job: Be at the forefront of innovation, making a real impact on patient lives.
- Qualifications: Bachelor’s in life sciences; experience in clinical study management required.
- Other info: Ideal for those passionate about advancing healthcare through cutting-edge research.
The predicted salary is between 43200 - 72000 £ per year.
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.
Clinical Trial Manager employer: Albion Rye Associates
Contact Detail:
Albion Rye Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trial Manager
✨Tip Number 1
Make sure to familiarize yourself with the latest advancements in cell and gene therapy. This knowledge will not only help you stand out during interviews but also demonstrate your genuine interest in the field.
✨Tip Number 2
Network with professionals in the biotech industry, especially those who have experience in clinical trials. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed clinical trials in the past. Highlight your experience with regulatory compliance and patient recruitment strategies, as these are crucial for the role.
✨Tip Number 4
Research our company’s recent projects and publications. Being knowledgeable about our work will allow you to ask insightful questions during the interview and show that you're genuinely interested in joining our team.
We think you need these skills to ace Clinical Trial Manager
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Clinical Study Manager position. Understand the key responsibilities and requirements, and think about how your experience aligns with them.
Tailor Your CV: Customize your CV to highlight relevant experience in clinical trial management, particularly in cell and gene therapy. Use specific examples that demonstrate your expertise in study planning, regulatory compliance, and team leadership.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for innovative therapies and improving patient outcomes. Mention why you are excited about the opportunity to work with this pioneering biotech company.
Highlight Relevant Skills: In your application, emphasize your knowledge of ICH-GCP guidelines, experience with clinical trial management systems, and your ability to manage multiple priorities. These skills are crucial for the role and should be clearly articulated.
How to prepare for a job interview at Albion Rye Associates
✨Showcase Your Experience
Be prepared to discuss your previous experience as a Clinical Study Manager, especially in cell and gene therapy trials. Highlight specific projects you've led, focusing on your role in study planning, execution, and compliance with regulatory guidelines.
✨Demonstrate Team Leadership Skills
Since collaboration is key in this role, share examples of how you've successfully led cross-functional teams. Discuss how you facilitated effective communication and resolved issues during clinical trials.
✨Understand Regulatory Compliance
Familiarize yourself with ICH-GCP, MHRA, and EMA regulations. Be ready to explain how you ensure compliance in your studies and provide examples of essential documents you've prepared, such as clinical study protocols and CTAs.
✨Discuss Patient Recruitment Strategies
Prepare to talk about your strategies for optimizing patient recruitment and retention. Share any successful initiatives you've implemented and how you built relationships with investigators and site staff to enhance study outcomes.
