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Clinical Trial Operations Manager
hace 2 meses
We are seeking a highly motivated and detail-oriented Clinical Trial Operations Manager to join our team at Pharmiweb. As a Clinical Trial Operations Manager, you will be responsible for coordinating and managing clinical trials from start to finish, ensuring timely and efficient execution of trial activities.
Key Responsibilities- Study Coordination: Coordinate and manage clinical trials, including study start-up, site management, and close-out.
- Communication: Communicate effectively with internal stakeholders, including project managers, clinical research associates, and site staff, as well as external stakeholders, including sponsors and site investigators.
- Documentation: Maintain accurate and up-to-date documentation, including study files, site files, and regulatory documents.
- Regulatory Compliance: Ensure compliance with regulatory requirements, including ICH-GCP, 21 CFR Part 11, and other relevant regulations.
- Quality Assurance: Identify and implement quality assurance measures to ensure high-quality trial execution.
- Collaboration: Collaborate with cross-functional teams, including clinical operations, data management, and biostatistics, to ensure seamless trial execution.
- Education: Bachelor's degree in a life science or related field.
- Experience: Minimum 2 years of experience in clinical trial operations, including study coordination, site management, and regulatory compliance.
- Skills: Excellent communication and organizational skills, with the ability to work in a fast-paced environment.
- Knowledge: Strong knowledge of clinical trial regulations, including ICH-GCP and 21 CFR Part 11.
- Competitive Salary: A competitive salary and benefits package.
- Opportunities for Growth: Opportunities for career growth and professional development.
- Collaborative Environment: A collaborative and dynamic work environment.
