Clinical Research Associate Manager
Summary
About the Role
#LI-Hybrid
Location: Amsterdam, Netherlands
Key Responsibilities
- Lead hiring, training, and retention of CRAs for Phase I–IV global clinical trials
- Support recruitment strategies and site performance in collaboration with Clinical Project Managers
- Ensure monitoring quality, timely data entry, and resolution of trial-related issues
- Identify and resolve CRA competency gaps through targeted training and co-monitoring visits
- Promote compliance culture and uphold ethical standards in trial execution
- Manage CRA performance and implement development and improvement plans
- Coach CRAs on risk-based monitoring processes and related systems
- Execute annual CRA oversight visits to assess competency and resolve issues
- Collaborate with CPMs to address monitoring trends and training needs
- Ensure adherence to clinical data standards, GCP, SOPs, and regulatory requirements
- Supports Clinical Development Audits, site audits and inspection and ensures CAPA follow-up and implementation for CRA and site identified issues
- Develop and implement local monitoring resource strategy
Essential Requirements
- Minimum 7 years of experience in clinical research, including planning and monitoring clinical trials
- Proven leadership in project management and team development within clinical operations
- Strong understanding of clinical drug development and trial execution processes
- Excellent communication and relationship-building skills with internal and external stakeholders along with strong presentation skills.
- Proficiency in digital tools and technology relevant to clinical trial management
- Fluency in Dutch is required for this role, in addition to English
Desirable Requirements
- Experience with risk-based monitoring strategies and implementation in global clinical trials
- Ability to travel domestically for site visits, training, and meetings
Commitment To Diversity And Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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