job title: Study Start-Up CRA(novartis)

Key Responsibilities:

• Lead and execute site selection and start-up activities from country allocation to site greenlight.

• Serve as the main point of contact for trial sites during start-up, including IRB/IEC and Health Authority submission preparation.

• Ensure timely collection and submission of site-specific documents (e.g., CVs, GCP certificates, financial disclosures).

• Support the preparation of country-specific documents and patient-facing materials.

• Coordinate vendor setup and assist with financial contract negotiations with investigational sites.

• Maintain accurate and up-to-date documentation in Trial Master File (TMF) and internal systems.

• Collaborate with internal stakeholders to ensure seamless handover to execution CRAs and readiness for audits and inspections.

Essential Requirements:

• Bachelor’s degree in a scientific or health discipline; clinical operations experience preferred.

• Minimum 3 years of experience in clinical operations, particularly in site management or monitoring.

• Strong knowledge of ICH/GCP guidelines, local regulatory requirements, and clinical trial processes.

• Excellent interpersonal, negotiation, and conflict resolution skills.

• Proven ability to manage multiple priorities and adapt to fast-changing environments.

• Willingness and ability to travel for site visits and meetings.