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Biotech
The Clinical Research Associate ensures trial participant rights and data integrity, manages site relationships, and oversees clinical trial compliance with regulations and guidelines.
Biotech
Lead operational strategy for complex early phase trials (FIH, HV, SAD/MAD, adaptive designs). Develop integrated delivery models, scenario budgets, and risk mitigations; drive cross-functional alignment, prepare executive bid defenses, maintain audit-ready documentation, and mentor junior strategists to ensure scalable, high-quality early clinical development execution.
Biotech
Provide in‑house support to clinical teams by managing study documentation (TMF/ISF), maintaining CTMS data and site compliance, coordinating trial materials, assisting monitoring visit preparation, and supporting regulatory submission tasks per ICH GCP and company SOPs.
