As a Clinical Data Specialist, you will play a key role in managing clinical trials efficiently and ensuring adherence to compliance and quality standards. Below are the core responsibilities:
- Project and Operations Management:
- Contribute to all phases of clinical trials, including planning, execution, and close-out activities.
- Ensure trials are delivered on time, within budget, and according to performance standards.
- Lead specific aspects of clinical trials under appropriate oversight as a core member of the Clinical Trial Team.
- Study Start-Up Activities:
- Oversee the development of key trial documentation, including protocols, case report forms (CRFs), and informed consent forms.
- Collaborate in identifying and analyzing potential new sites for trials.
- Site Monitoring and Trial Close-Out:
- Oversee site close-out activities, including drug accountability and audit readiness of Trial Master Files (TMF).
- Ensure proper handling of study conduct and reporting activities for clinical operations.
- Compliance and Reporting:
- Promote adherence to Novartis SOPs, best practices, and external regulations.
- Educate team members on clinical data review processes and operational standards.
- Report adverse events or product-related complaints within 24 hours, as per company policy.
Novartis is a global healthcare leader with a mission to improve patient outcomes through innovative medicines. The company’s commitment to research, quality, and compliance has made it a preferred partner for groundbreaking clinical research. With offices worldwide, Novartis is known for creating a work environment that nurtures talent, drives innovation, and upholds the highest ethical standards.
