Clinical Research Associate Manager

2 weken geleden

Amsterdam, Nederland Novartis Voltijd

**Summary**:
As a Clinical Research Associate Manager, you’ll empower and guide a team of CRAs to deliver high-quality, compliant, and timely trial execution. Your influence will drive recruitment strategies, ensure monitoring excellence, and foster a culture of integrity and innovation. If you're passionate about mentoring talent, making a meaningful impact in clinical trials, and stepping into a local leadership role where your expertise in clinical research will directly shape the future of global drug development, this is your opportunity to lead with purpose.

**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.

Division

Development

Business Unit

Universal Hierarchy Node

Location

Netherlands

Site

Amsterdam

Company / Legal Entity

NL08 (FCRS = NL008) Novartis Pharma NL

Functional Area

Research & Development

Job Type

Full time

Employment Type

Temporary (Fixed Term)

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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