Sr. Clinical Research Associate/Clinical trial Manager
Core
Sr. Clinical Research Associate/Clinical Trial Manager supporting global clinical studies from planning to close-out, ensuring quality oversight and risk management for patients with genetic diseases.
Role type
Senior IC Clinical Operations Manager
Builds
Clinical studies for genetic disease treatments (e.g., FGFR-driven skeletal dysplasia)
Domain
Biopharmaceuticals / Rare Diseases
Required skills
Clinical study oversight, Vendor management (CROs), Risk-based quality management, Protocol execution, Regulatory compliance (GCP/ICH), Budget negotiation, Cross-functional collaboration
Preferred skills
Biotechnology/pharma sponsor experience, Global study experience, ICH E6(R3) principles
Technologies
SmartSheet, MS Office Suite
Responsibilities
Lead operational management for assigned regions and sites; Manage CRO and key vendor performance; Oversee CRO monitors and review documentation; Contribute to study document development; Ensure Trial Master File readiness; Resolve protocol and safety questions; Negotiate site budgets and contracts.
Seniority
Senior, hands-on IC
