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clinical operations cro etmf ctms tmf📋 Description
- Assist in planning and conduct of global oncology trials (Phases 1–3).
- Support start-up, monitoring, and close-out activities.
- Coordinate CROs/vendors and oversee timelines and budgets.
- Maintain eTMF and CTMS systems and related documentation.
- Track site approvals, regulatory docs, and enrollment status.
- Provide updates and action plans to study teams.
🎯 Requirements
- Undergrad degree in Biological Sciences or related field; 1–2 yrs exp.
- 1–2 yrs clinical operations experience (Phases 1–3) in pharma/CRO.
- 1–2 yrs TMF/document management or clinical trial support.
- Experience with eTMF systems (Trial Interactive eTMF, Veeva Vault).
- Experience with CTMS (Trial Interactive CTMS, Medidata CTMS) preferred.
- ICH-GCP knowledge; US and ex-US regulations; cross‑functional teams.
🎁 Benefits
- Paid time off, holidays, and sick leave
- Medical, dental, and vision plans
- Short- and long-term disability
- Life/AD&D coverage (basic and voluntary)
- FSA/HSA and commuter benefits
- 401(k) with Erasca contribution and stock purchase plan
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