Ichnos Glenmark Innovation
Website:
iginnovate.com
Job details:
We are seeking an experienced eTMF Specialist to oversee electronic Trial Master File (eTMF) strategy and execution for our oncology clinical programs. This role ensures inspection readiness, regulatory compliance, and operational excellence in managing trial documentation across global oncology studies.
Overall Job Responsibilities:
1) eTMF Strategy & Oversight
- Lead eTMF planning, setup, and governance for oncology trials across all phases (I–III).
- Ensure alignment with ICH-GCP, FDA, EMA, and other global regulatory requirements.
2) Operational Excellence
- Oversee document collection, QC, and filing to maintain inspection-ready eTMFs.
- Drive process improvements and automation to enhance efficiency in oncology trial documentation.
3)Oncology-Specific Focus
- Partner with clinical operations and oncology study teams to ensure timely documentation of dose-escalation, expansion cohorts, biomarker-driven protocols, and adaptive designs.
- Support documentation for complex trial designs (e.g., basket/umbrella studies).
4)Cross-Functional Collaboration
- Collaborate with global clinical operations, data management, regulatory affairs, and pharmacovigilance to ensure accurate and complete trial documentation.
- Act as the primary point of contact for eTMF-related audits and inspections in oncology programs.
5)Compliance & Inspection Readiness
- Monitor eTMF health metrics and KPIs to ensure continuous inspection readiness.
- Lead responses to regulatory queries and inspection findings related to oncology eTMFs.
Education (degree/diploma)
- Bachelor’s or Master’s degree in Life Sciences, Clinical Research, or related discipline.
Experience
- 5+ years of clinical trial documentation/eTMF experience, with at least 5 years in oncology (solid tumors preferred).
- Proven track record of managing global eTMFs for complex oncology trials.
Knowledge and Skills (Functional / Technical)
- Strong knowledge of eTMF systems (e.g., Veeva Vault, Wingspan, or similar).
- Deep understanding of oncology trial designs, regulatory requirements, and inspection readiness standards.
- Experience with immuno-oncology, targeted therapies, or antibody–drug conjugates in solid tumors.
- Prior involvement in successful oncology regulatory submissions (INDs, NDAs, BLAs).
- Strong knowledge of oncology-specific documentation challenges (e.g., biomarker-driven protocols, adaptive designs).
- Ability to balance strategic oversight with hands-on operational management.
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