Related skills
gcp sop cro fda ivdπ Description
- Execute deliverables for assigned clinical studies (startups, site initiation, docs, closeout).
- Lead and mentor study staff (CRAs/CTAs).
- Manage vendor/CRO proposals, budgets, contracting, and management.
- Collaborate with CTMs to share lessons and implement best practices.
- Provide regular updates on study progress to stakeholders.
- Ensure compliance with SOPs, FDA/GCP and international regulations.
π― Requirements
- BA/BS and 6+ years in clinical trial mgmt; advanced degree preferred.
- Strong knowledge of clinical trial operations, design, enrollment, monitoring.
- Experience managing CROs and external vendors.
- Working knowledge of CFR Parts 11, 50, 54, 56, 812 and ICH GCP.
- Ability to work independently and lead/mentor teams; proven PM skills.
- Excellent problem-solving, verbal and written communication.
π Benefits
- Equity, bonuses, and comprehensive medical/financial benefits.
- Remote work with occasional in-person meetings at the Brisbane, California HQ.
- Equal opportunity employer; values diversity.
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