Note: The job is a remote job and is open to candidates in USA. Novartis is a leading pharmaceutical company focused on driving clinical trials forward. As a Senior Clinical Research Associate, you will manage site relationships and oversee monitoring activities to ensure the successful execution of clinical trials in compliance with regulatory standards.
Responsibilities
- Lead assigned sites as the primary point of contact throughout study delivery
- Build strong relationships to ensure site performance, quality, and milestone achievement
- Manage Phase I to Phase IV trials per monitoring plans and company procedures
- Conduct site initiation visits and deliver ongoing training for site personnel
- Perform remote and on-site monitoring to ensure compliance and patient safety
- Maintain accurate documentation and update all clinical systems in a timely manner
- Identify risks, resolve issues, and escalate concerns as needed
- Collaborate with cross-functional teams to drive efficient study execution
- Support timely data query resolution and ensure data accuracy
- Act as a subject matter expert across study activities when required
Skills
- Minimum of three years of clinical site monitoring experience
- Minimum of Bachelor's degree in science, healthcare, or a related field
- Strong understanding of clinical research and drug development processes
- Knowledge of ICH/GCP and 21 CFR regulatory requirements
- Ability to manage multiple priorities and work independently
- Strong site management, communication, and problem-solving skills
- Fluency in English, written and spoken, Spanish highly desired
- Ability to drive and travel extensively, up to 80%, in a company vehicle
- Experience in multiple therapeutic areas and Veeva Vault CTMS is a plus
- Advanced knowledge and use of AI
Benefits
- Performance-based cash incentive
- Eligibility to be considered for annual equity awards
- Comprehensive benefits package that includes health, life and disability benefits
- 401(k) with company contribution and match
- A variety of other benefits
- Generous time off package including vacation, personal days, holidays and other leaves
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