Sr. Clinical Trial Manager
New
USFull-TimeSenior
Salary149,860 - 181,595 USD per year
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Job Details
- Experience
- 5–7+ years
- Required Skills
- GCP
Requirements
- 5–7+ years of clinical operations experience in biotech, pharmaceutical, or CRO environments.
- Bachelor’s degree in a scientific or healthcare-related discipline preferred.
- Strong understanding of clinical trial lifecycle management, including study start-up, execution, and closeout.
- Solid knowledge of Good Clinical Practice (GCP) and ICH guidelines.
- Experience managing CROs, vendors, and cross-functional clinical study teams.
- Strong organizational, communication, and problem-solving skills.
- Ability to thrive in dynamic, fast-changing environments with competing priorities.
- Proficiency with tools such as Microsoft Project and Smartsheet is preferred.
Responsibilities
- Lead the planning, execution, and closeout of Phase I–III clinical trials, ensuring delivery against timelines, budget, and quality expectations.
- Oversee and manage CROs and vendors, ensuring compliance with SOPs, GCP/ICH guidelines, and applicable regulatory requirements from agencies such as the FDA.
- Drive cross-functional collaboration across clinical operations, data, regulatory, and medical teams to ensure study alignment and execution.
- Monitor study performance indicators including enrollment, site activation, data quality, and operational risks, escalating issues proactively when needed.
- Manage study budgets, contracts, and invoicing activities in collaboration with external partners.
- Support feasibility, site selection, and activation strategies to ensure optimal study execution.
- Summarize vendor and site performance and contribute to operational strategy and continuous improvement initiatives.
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