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gcp vendor management gdpr smartsheet sop📋 Description
- Lead cross-functional study teams to plan, execute, and deliver trials.
- Manage budgets and timelines; ensure GCP, SOP, and regulatory compliance.
- Champion collaboration and accountability across study delivery.
- Oversee CROs, vendors, and risk management to meet milestones.
🎯 Requirements
- Bachelor's degree in a scientific/medical field or equivalent.
- 10-12 years of Clinical Operations experience in biopharma.
- Led cross-functional trials; milestones, data review, reporting.
- Strong vendor management; eTMF, QA, SOP, CAPA.
- Deep knowledge of GCP, ICH E6 (R3), GDPR; rare/orphan studies preferred.
- Proven leadership with strong communication; Smartsheet a plus.
- Travel required periodically.
🎁 Benefits
- Market-competitive total rewards package (base pay, bonus, equity).
- Annual performance bonus.
- Company equity.
- Generous health benefits.
- Remote U.S.-based role with quarterly SF office visits.
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