직무 설명

Assist in collecting, preparing, and adapting documents for submissions to Institutional Review Boards (IRB)/Ethics Committees (EC) and Health Authorities as required.
Manage Investigator Files (IF) and Trial Master Files (TMF) at both country and site levels, ensuring set-up and continual maintenance in compliance with regulatory standards and Novartis policies; oversee document tracking and control.
Support the onboarding process for vendors when applicable.
Verify completeness of site readiness documentation ("Green Light") to guarantee all materials are in order for initial and successive drug releases in partnership with local Qualified Persons.
Contribute to the preparation and translation of Informed Consent Forms (ICF) into local languages, including coordinating with vendors if necessary.
Ensure all trial-related documents are fully uploaded into the Trial Master File and manage archiving of physical paper TMFs.
Collaborate closely with the Site Start-Up (SSU) Team Lead and SSU Managers to support country-specific SSU strategies, meeting all SSU deadlines and deliverables as per commitments.
Maintain compliance with financial guidelines, applicable laws, ICH/GCP standards, IRB/IEC protocols, Health Authority regulations, and internal Standard Operating Procedures (SOPs).
Provide logistical assistance to SSU CRAs, CRAs, CPMs, and SSU Managers across all clinical trial stages.
Apply innovative and resource-efficient process improvements aligned with Novartis's strategic goals.

Possess a degree or an equivalent qualification in a scientific, medical, or related discipline, with at least one year of exposure to clinical operations preferred.
Demonstrate foundational understanding of clinical drug development processes, especially study start-up, regulatory submissions, and contracting workflows.
Have knowledge of ICH/GCP guidelines, IRB/IEC, and Health Authority requirements and ensure consistent compliance in everyday tasks.
Experience supporting preparation, collection, tracking, and upkeep of regulatory documents and TMFs to guarantee completeness and readiness for audits.
Ability to assist with submissions to IRB/EC and Health Authorities, including document preparation and necessary adaptations.
Skilled in maintaining study management systems such as document repositories and tracking tools, ensuring prompt and accurate document uploads.

Clinical Trial Associate