Clinical Trial Manager Associate, Clinical Operations
New
J
JobgetherOncology clinical trials
Based in United StatesFull-TimeJunior
Salary$107,508–$130,274 USD annually
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Job Details
- Experience
- 2–3 years of clinical operations experience within the biotechnology, pharmaceutical, or CRO industry.
- Required Skills
- GCP
Requirements
- Have 2–3 years of clinical operations experience within the biotechnology, pharmaceutical, or CRO industry.
- Have experience managing or supporting clinical study vendors, including familiarity with vendor deliverables, performance monitoring, and issue escalation.
- Have working knowledge of clinical trial processes and applicable GCP, ICH, FDA, and SOP requirements.
- A bachelor’s degree in a scientific, healthcare, or related discipline is preferred.
- Bring strong organizational skills and exceptional attention to detail, with a consistent focus on quality.
- Provide clear and timely updates to internal and external stakeholders.
- Work independently and contribute effectively within cross-functional teams.
- Adapt to changing priorities in a dynamic environment.
- Identify problems and drive them toward resolution.
- Experience with Microsoft Project and Smartsheet is desirable.
- Be willing and able to travel up to 10% as business needs require.
Responsibilities
- Manage clinical study vendors, including central laboratories, RTSM/IRT, imaging, dosimetry, and other specialized providers.
- Participate in vendor meetings, operational planning, risk mitigation, and performance reviews using KPIs and vendor metrics.
- Support the Study Lead with CRO activities, including reviewing protocols, informed consent forms, study plans, and other essential documents.
- Contribute to CRO and Study Execution Team meetings and study and country start-up planning.
- Support site feasibility assessments, site selection, site initiation, and resolution of operational issues.
- Maintain essential study documentation and support Trial Master File completeness, accuracy, and quality.
- Monitor vendor progress, identify emerging risks or delays, and escalate issues to internal stakeholders.
- Support vendor budgets, contract-related activities, and invoice management while monitoring financial performance.
- Summarize vendor performance and study status for the Study Lead and contribute to risk identification and mitigation.
- Collaborate with clinical operations and other functional teams to maintain study quality, timelines, and compliance.
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