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Regulatory Affairs Specialist
2 months ago
**Job Title:** Clinical Trials Manager
**Company:** Pharma Partners Recruitment Ltd
**Job Summary:** We are seeking a highly skilled Clinical Trials Manager to join our team. As a Clinical Trials Manager, you will be responsible for overseeing all aspects of clinical trial management, ensuring the successful execution of trials from participant identification to data collection.
**Key Responsibilities:**
- Design and author trial documentation and regulatory submissions, ensuring compliance with regulatory standards.
- Monitor trial progress and performance, identifying and addressing any issues that may arise.
- Collaborate with cross-functional teams, including central study teams and operational staff, to ensure seamless trial execution.
- Develop and maintain high-quality, auditable systems for trial conduct, ensuring adherence to regulatory standards.
**Requirements:**
- Proven experience in clinical trials management, with a strong understanding of regulatory requirements.
- Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR, and Research Governance Framework Legislation.
- Strong analytical and problem-solving skills, with the ability to work in a fast-paced environment.
- Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
**What We Offer:**
A highly competitive salary and benefits package, as well as opportunities for professional growth and development.
