Novartis is seeking a Study Start-Up Clinical Research Associate (SSU CRA) to oversee and execute site selection, regulatory submissions, and trial activation for Phase I–IV clinical trials. This role is crucial in ensuring compliance with ICH/GCP guidelines and local regulations while facilitating smooth trial initiation.
Key Responsibilities:
✔ Lead site selection, feasibility assessments, and start-up activities from country allocation to site activation.
✔ Serve as the primary contact for trial sites, IRB/IEC, and health authorities during the start-up phase.
✔ Ensure timely collection of essential documents (CVs, GCP certifications, financial disclosures).
✔ Prepare and submit regulatory and ethics committee applications.
✔ Coordinate vendor setup, site contracts, and budget negotiations.
✔ Maintain Trial Master File (TMF) compliance and ensure audit readiness.
✔ Collaborate with cross-functional teams for seamless handover to execution CRAs.
Essential Requirements:
✅ Bachelor’s degree in life sciences, pharmacy, or related field.
✅ 3+ years in clinical operations, site management, or monitoring.
✅ Strong knowledge of ICH-GCP, clinical trial regulations, and site activation processes.
✅ Excellent communication, negotiation, and problem-solving skills.
✅ Ability to manage multiple priorities in a fast-paced environment.
✅ Willingness to travel for site visits as needed.
About Novartis
Novartis is a global healthcare leader committed to reimagining medicine through innovative science. With a focus on cardiology, immunology, neuroscience, and oncology, Novartis delivers life-changing therapies to millions worldwide.
Why Join Novartis?
✨ Impactful Work: Contribute to cutting-edge clinical trials that improve patient lives.
✨ Inclusive Culture: Novartis fosters diversity, equity, and inclusion in the workplace.
✨ Career Growth: Opportunities for professional development and global collaboration.
✨ Work-Life Balance: Hybrid work model with flexible arrangements.
