Senior Clinical Trial Manager
New
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Iambic Therapeutics, IncBiotech
Remote - USFull-TimeSenior
Salary152,000 - 190,000 USD per year
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Job Details
- Experience
- 7+ years
- Required Skills
- Risk Management
Requirements
- Bachelor’s degree in life sciences or related field
- 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, and/or CRO environments
- Demonstrated expertise managing clinical trials from start-up through close-out
- Experience overseeing global, multi-site studies and CRO partners
- Experience in oncology clinical trials
- In-depth knowledge of ICH-GCP, FDA/EMA regulations, and global regulatory requirements
- Proficiency with CTMS, eTMF platforms, IRT systems, EDC systems, and safety databases
Responsibilities
- Provide end-to-end operational leadership for complex clinical trials from start-up through close-out, ensuring delivery on time, within budget, and in compliance with global regulations and company SOPs
- Lead cross-functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners
- Develop and execute enrollment, site management, and monitoring strategies to ensure high-quality trial conduct and performance
- Oversee CRO and vendor performance, including KPI management, monitoring quality oversight, document review and approval, and vendor selection support
- Partner with Data Management and Medical to conduct ongoing data review and ensure timely query resolution
- Develop and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials.
- Lead study-related training for investigators, site personnel, and internal teams.
- Proactively identify, assess, and escalate operational risks with mitigation strategies and clear recommendations.
- Mentor and support junior clinical operations staff, including potential dotted-line management responsibilities.
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