Clinical Trials Manager
4 days ago
Job Summary:
We are seeking an experienced Clinical Trials Manager to join our team at Pharma Partners Recruitment Ltd. As a Clinical Trials Manager, you will be responsible for the overall management of clinical trials, ensuring they are conducted in accordance with regulatory standards and company policies.
Key Responsibilities:
- Design and author trial documentation and regulatory submissions, ensuring compliance with EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR, and Research Governance Framework Legislation.
- Monitor trial progress and performance, from participant identification and recruitment to data collection, ensuring timely and within-budget delivery.
- Serve as the operational point-of-contact between the central study team and other operational staff, including CRA's/Senior CRA's.
- Ensure the department maintains a high-quality, auditable system for standardizing trial conduct in accordance with regulatory standards.
Requirements:
- Proven clinical trial experience, with a working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR, and Research Governance Framework Legislation.
- Working knowledge of BS EN ISO 14155.
- A life science degree would be advantageous.
What We Offer:
A highly competitive salary and benefits package, reflecting the company's commitment to attracting and retaining top talent in the industry.
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