Senior Clinical Trial Manager, Clinical Operations

Iambic Therapeutics, Inc.

Job Overview

Location

Remote - US

Job Type

Full-time

Full Job Description

📋 Description

• Serve as the operational lead for early-phase oncology clinical trials, managing end-to-end execution from start-up through close-out, ensuring timely, budget-compliant, and regulatory-compliant delivery
• Lead cross-functional study teams including Clinical Development, Regulatory, Biometrics, Data Management, and Medical, ensuring alignment and efficient trial execution
• Oversee performance and quality of external CROs and vendors, including KPI monitoring, document review and approval, vendor selection support, and quality oversight
• Develop and implement enrollment, site management, and monitoring strategies to ensure high-quality trial conduct and optimal patient recruitment
• Manage key study documents including protocols, informed consent forms, project plans, budgets, and study materials, ensuring compliance with ICH-GCP, FDA/EMA regulations, and company SOPs
• Partner with Data Management and Medical teams to conduct ongoing data reviews and drive timely resolution of data queries
• Conduct training for investigators, site personnel, and internal teams on trial procedures, protocols, and regulatory expectations
• Proactively identify, assess, and escalate operational risks with actionable mitigation strategies and clear recommendations
• Mentor and support junior clinical operations staff, including potential dotted-line management responsibilities
• Travel up to 10% to support site visits, investigator meetings, and trial oversight activities
• Ensure all trial activities are inspection-ready and aligned with global regulatory requirements and quality standards
• Collaborate with Clinical Operations leadership to align trial strategies with company goals in a fast-paced, growth-stage biotech environment
• Utilize clinical trial systems including CTMS, eTMF, IRT, EDC, and safety databases to manage trial data and operations
• Contribute to the development and optimization of operational tools and processes to enhance trial efficiency and compliance
• Maintain a strong focus on quality, compliance, and patient safety throughout all phases of clinical trial execution
• Work remotely or onsite in San Diego, with flexibility to support team needs across the U.S.

🎯 Requirements

• Bachelor’s degree in life sciences or related field with 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, or CRO environments
• Demonstrated expertise managing global, multi-site oncology clinical trials from start-up through close-out, with experience overseeing CRO partners
• Direct experience in oncology trials, with preference for solid tumor and early-phase (Phase I/Ib or II) studies
• In-depth knowledge of ICH-GCP, FDA/EMA regulations, and global regulatory requirements with a focus on inspection readiness
• Proficiency with clinical trial systems including CTMS, eTMF, IRT, EDC, and safety databases
• Proven ability to thrive in a fast-paced, growth-stage biotech environment with evolving priorities and high accountability

🏖️ Benefits

• Industry-leading competitive pay
• Company-paid healthcare
• Flexible spending accounts
• Voluntary life insurance
• 401K matching
• Uncapped vacation

Skills & Technologies

GCP

Senior

Remote

Degree Required

Ready to Apply?

Apply Externally

You will be redirected to an external site to apply.

AI Job Fit Analysis

Pro

See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.

Iambic Therapeutics, Inc.

Visit Website

About Iambic Therapeutics, Inc.

Iambic Therapeutics is a biotechnology company leveraging a cutting-edge, AI-driven platform to revolutionize drug discovery and develop superior medicines. Utilizing physics-based AI algorithms and high-throughput experimental processes, Iambic addresses challenging design problems to generate optimized drug candidates and explore novel mechanisms of action. Their platform-driven pipeline focuses on first-in-class and best-in-class programs, including a HER2 program already in Phase 1 clinical studies, aimed at unlocking the potential of known targets and transforming undruggable targets into breakthrough treatments for patients with unmet medical needs. This innovative approach enables them to deliver differentiated clinical candidates at an accelerated pace, supported by over $100 million raised in an oversubscribed financing round to advance their portfolio.

View Company Profile

Get more remote jobs like this

Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.

Weekly remote jobs and featured talent.

No spam. Only curated remote roles and product updates. You can unsubscribe anytime.