Clinical Trial Manager (CTM)

Role

Senior Clinical Trial Manager responsible for end-to-end management of assigned clinical trials in biopharma, with a focus on drug development processes.

Responsibilities

• oversee trial operations, manage CRO/vendor relationships, ensure compliance with GCP, FDA, EMA, and ICH regulations;
• collaborate with Data Management on CRFs and data deliverables;
• coordinate with study teams, site investigators, and stakeholders;
• monitor enrollment, trial progress, and budgets;
• prepare for audits and inspections;
• identify risks and implement solutions.

Requirements

• B.S. in biological sciences or related field;
• 5+ years of industry experience managing clinical trials independently;
• strong knowledge of regulatory guidelines;
• excellent communication, organization, and problem-solving skills;
• ability to travel (~25%).

Preferred

• experience in oncology, immunology, or inflammatory diseases;
• familiarity with targeted protein degradation modalities;
• experience in early-phase (Ph1-3) trials.

HighValue

full trial lifecycle ownership, vendor management, regulatory compliance, and cross-functional team leadership in a fast-paced, innovative biopharma environment.

Work Setup

onsite in Brisbane, CA; travel required.