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budgeting edc cro irt fda📋 Description
- Manage global oncology trials (Ph1-3) per ICH-GCP and FDA requirements.
- Recruit global study sites and investigators.
- Participate in site and vendor qualification and activation.
- Develop RFIs/RFPs and assist vendor selection.
- Manage study vendors (CRO, IRT, labs, ECG/imaging).
- Monitor enrollment and trial materials; provide updates to management.
🎯 Requirements
- Undergraduate degree in life sciences or allied health fields.
- 5+ years oncology clinical operations; Senior: 7+ years.
- Strong trial management across multiple projects and priorities.
- Experience with CRO, IRT, labs, and ECG/imaging.
- Ability to work with global, multi-disciplinary teams.
- ICH-GCP and US/ex-US regulations; experience with EDC and data management; CRA oversight.
🎁 Benefits
- Paid Time Off, Holidays, Sick Leave
- Medical, Dental and Vision Coverage
- Short- and Long-Term Disability
- Life/AD&D, FSA/HSA, and commuter benefits
- Pet Insurance and Employee Assistance Program
- 401(k) Plan with Erasca contributions and stock purchase program
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