- 经验
- 1年以上
- 薪水
- —
- 职位空缺
- 1
- 发布
- 1 小时前
- 工作模式
- 在办公室
- 学历
- Degree or equivalent in scientific, medical, or related field
- 恢复
- 需要申请
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职位描述
Key Responsibilities
- 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.
Essential Requirements
- 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.