
Clinical Research Leader
2 days ago
As a Clinical Research Manager, you will play a crucial role in leading and managing the end-to-end performance of assigned clinical trial protocols within a designated country. Your primary responsibility will be to ensure compliance with ICH/GCP guidelines, country regulations, and company policies and procedures.
Key Responsibilities:
- Act as the primary contact for assigned protocols, coordinating efforts between Country Operations and the Clinical Trial Team (CTT)
- Manage project timelines and performance metrics, ensuring all country commitments are met
- Review Monitoring Visit Reports, escalating issues and training compliance to managers as necessary
- Lead local study teams, providing training and support on protocols to enhance performance
- Create and execute local risk management plans for assigned studies
- Ensure compliance with CTMS, eTMF, and other essential systems
- Collaborate with outsourcing vendors, investigators, internal stakeholders, and external partners to facilitate study success
Required Skills and Qualifications
To be successful in this role, you must possess:
- Bachelor's degree in Science or related field with 5+ years of clinical research experience
- Previous experience as a Clinical Research Associate (CRA) or Clinical Research Manager (CRM)
- Strong organizational skills and ability to make independent decisions
- In-depth understanding of local regulatory environment and clinical trial management
- Effective communication skills and ability to work collaboratively in a remote/virtual environment
- Proficiency in written and spoken English and local language
- Proven project management skills or relevant certification/training
Benefits
Our company offers a range of benefits, including:
- A competitive salary and bonus structure
- A comprehensive benefits package, including health insurance and retirement plan
- Opportunities for career advancement and professional development
- A dynamic and supportive work environment
Others
We are committed to flexible working where possible and have introduced a new hybrid working model for office-based colleagues around the world. If you are ready to invent solutions to meet unmet healthcare needs, please apply today.
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