Clinical Trial Manager
New
United States, Support teams across multiple time zones.Full-TimeManager
Salary116,960 - 160,820 USD per year
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Job Details
- Experience
- Minimum of 8 years of experience in the pharmaceutical, biotechnology, diagnostics, or CRO industry, including 5+ years of experience as a CRA/Senior CRA.
- Required Skills
- Project ManagementGCPBudget management
Requirements
- Bachelor's degree in a scientific, clinical, or health-related discipline; advanced degree preferred.
- Minimum of 8 years of experience in the pharmaceutical, biotechnology, diagnostics, or CRO industry.
- 5+ years of experience as a CRA/Senior CRA.
- Strong knowledge of GCP, ICH guidelines, FDA regulations, and global clinical research requirements.
- Proven experience managing CROs, vendors, and external study partners.
- Demonstrated project management, organizational, and budget management skills.
- Strong analytical, problem-solving, communication, and stakeholder management skills.
- Proficiency with Microsoft Office, eTMF, and EDC systems.
- Experience supporting regulatory submissions, inspections, and audit readiness.
- Ability to travel up to 25% and support teams across multiple time zones.
- Sound judgment in responsibly leveraging AI-enabled tools.
Responsibilities
- Lead the planning, execution, and oversight of assigned clinical studies from study start-up through closeout.
- Partner cross-functionally with Medical Affairs, Data Management, Clinical Operations, Regulatory Affairs, and external vendors.
- Oversee and manage CROs, vendors, and investigational sites, including monitoring visit report reviews.
- Manage study timelines, enrollment metrics, vendor performance, budgets, and payments.
- Identify operational risks and implement mitigation strategies for successful study completion.
- Collaborate with Legal and sites to support contract and budget negotiations.
- Lead study team meetings and provide updates to stakeholders and senior management.
- Contribute to study-related documentation including protocols, informed consent, and manual preparation.
- Support data review, database lock, regulatory submissions, and audit readiness activities.
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