Novartis, a global leader in reimagining medicine, is dedicated to improving and extending people’s lives. With an unwavering commitment to innovation, diversity, and collaboration, Novartis stands out as a trusted and valued name in the pharmaceutical industry. If you’re passionate about advancing healthcare and contributing to groundbreaking solutions, a career at Novartis offers the perfect platform to thrive.
Responsibilities in the Job
As a Clinical Research Associate (CRA) at Novartis, you will play a pivotal role in ensuring the successful execution of clinical trials. Your responsibilities include:
- Site Relationship Management:
- Act as the primary liaison between Novartis and trial sites to foster effective collaboration.
- Ensure trial sites meet expectations in deliverables and performance.
- Monitoring and Compliance:
- Conduct on-site and remote monitoring of Phase I-IV Global Drug Development (GDD) trials.
- Perform site initiation visits, ensuring thorough training for all trial-related personnel.
- Ensure adherence to protocols, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) / Good Clinical Practice (GCP), local regulations, and Standard Operating Procedures (SOPs).
- Data and Quality Assurance:
- Proactively manage site performance, focusing on recruitment and data quality.
- Advocate for compliance and ethical integrity to ensure human subject protection and reliable trial results.
- Audit and Inspection Readiness:
- Participate in audits and inspection readiness activities, ensuring the implementation of corrective actions as needed.
Qualifications and Skills
To be eligible for this role, you should possess:
- Educational Background:
- A degree in a scientific or healthcare discipline.
- Experience:
- A minimum of 2 years in the pharmaceutical industry or relevant experience.
- Prior experience in central/in-house or field monitoring.
- Technical Knowledge:
- Familiarity with international standards such as ICH/GCP, FDA, and EMA regulations.
- An understanding of the core CRA responsibilities, including patient safety, data integrity, and protocol compliance.
- Soft Skills:
- Strong communication and organizational skills.
- A proactive approach to problem-solving and collaboration.