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gcp edc ich microsoft project nda📋 Description
- Leads global clinical trial from start-up to close-out, on time and on budget.
- Oversees clinical operations personnel assigned to the trial.
- Partners with Clinical Development, Regulatory, Data Mgmt, Biostatistics, and Safety for efficient trial execution.
- Establishes strong relationships with investigators and KOLs.
- Contributes to study docs: protocols, ICFs, monitoring plans, EDC specs, SAPs.
- Manages CROs, vendors, and external partners for quality and adherence.
🎯 Requirements
- Bachelor’s degree in science/healthcare or equivalent.
- 10+ years leading Phase 3 oncology/hematology trials in US/Asia/Europe.
- Experience managing CROs, vendors, contracts, and clinical finance.
- Deep knowledge of GCP and ICH guidelines.
- Ability to work independently in a fast-paced, matrixed team.
- Proficiency with Microsoft Project.
🎁 Benefits
- Career advancement and development opportunities.
- Competitive compensation and annual bonus.
- 401K with employer contributions.
- Generous stock options and ESPP.
- Paid time off and holidays.
- Comprehensive benefits package.
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