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Clinical Trials Manager
2 months ago
**Job Summary:**
i-Pharm Consulting is seeking a highly experienced Clinical Trials Manager to join our team in the EU Operations department. As a Clinical Trials Manager, you will be responsible for managing interventional clinical trials across Europe, ensuring all studies are executed in line with regulatory requirements and company guidelines.
**Key Responsibilities:**
- **Manage Clinical Studies:** Oversee all components of small clinical studies, including Phase I trials, from initiation to close-out.
- **Vendor Management:** Coordinate with Contract Research Organisations (CROs) and other vendors to ensure project deliverables are met.
- **Study Logistics:** Develop and implement study logistics and plans to meet clinical study objectives.
- **Monitor Progress:** Provide oversight for site evaluations, initiation, routine monitoring visits, and study close-outs, ensuring all processes adhere to SOPs and regulatory requirements.
- **Team Collaboration:** Work closely with cross-functional teams and contribute to SOP development and process improvements.
**Requirements:**
- **Education:** PharmD/PhD with 2+ years, MA/MS with 3+ years, or BA/BS/RN with 5+ years of relevant clinical or related experience in life sciences.
- **Experience:** Proven experience managing clinical trials in Europe, ideally with monitoring experience or strong country management skills.
- **Skills:** Advanced knowledge of study management, regulatory guidelines (FDA, EMA, ICH, GCP), and protocol requirements. Excellent communication and adaptability skills, with a team-oriented approach.
**About i-Pharm Consulting:**
i-Pharm Consulting is a leading pharmaceutical consulting company that provides expert services to the life sciences industry. Our team of experienced professionals is dedicated to delivering high-quality solutions that meet the needs of our clients.