Clinical Trial Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee operational functions throughout all stages of clinical studies, encompassing feasibility, initiation, maintenance, and closure.

• Assist in the planning and execution of studies, which includes identifying, evaluating, qualifying, and supervising sites and vendors.

• Execute operational strategies that enhance patient enrollment, site monitoring, and trial implementation.

• Manage clinical trial operations from the start of the study until the completion of the Clinical Study Report.

• Create and oversee study tools, documentation, timelines, trackers, communications, and essential study documents.

• Identify, evaluate, monitor, mitigate, and document operational risks at the trial level.

• Arrange study meetings, including agendas, minutes, presentations, and action items.

• Provide oversight for Sponsor activities related to CRO and vendor performance, deliverables, metrics, and governance.

• Coordinate logistics for investigational products, laboratory, sample management, and study supplies.

• Conduct ongoing reviews of Sponsor data, manage queries, evaluate protocol deviations, review safety information, and resolve issues.

• Examine monitoring reports and engage in monitoring or oversight visits as necessary.

• Maintain the Trial Master File and ensure readiness for inspections.

• Review or authorize site-specific documents, including informed consent forms, site budgets, and monitoring reports.

• Facilitate audits, inspections, investigator and site training, process enhancements, and strategic initiatives.

• Communicate trial updates, operational risks, and mitigation strategies to stakeholders.

• Collaborate with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Monitoring, Drug Supply, Quality Assurance, Safety, and other cross-functional teams.

⛳️ Requirements

• BS degree in life sciences with a minimum of 6+ years of experience in Clinical Operations, or an MS degree in life sciences with at least 4+ years of Clinical Operations experience.

• Minimum of 3 years of experience in Sponsor Clinical Trial Management.

• Proven experience in supporting complex global Phase III clinical trials.

• Experience in cell therapy or oncology.

• Strong knowledge of ICH-GCP, FDA, EMA, and relevant global regulatory requirements.

• Demonstrated expertise in technology utilization, documentation standards, and sound business judgment.

• Advanced skills in Microsoft 365, including Word, Excel, PowerPoint, Outlook, and SharePoint.

• Exceptional attention to detail and dedication to high-quality outcomes.

• Outstanding written and verbal communication skills, along with strong interpersonal abilities.

• Willingness to travel up to 20% based on business requirements.

• Legal authorization to work in the United States.

🏝️ Benefits

• Comprehensive compensation package that includes a competitive salary, bonus, and equity options.

• Salary range of $160,000–$175,000.

• Generous paid vacation time.

• Holidays observed by the company.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement savings plan with employer matching contributions.

• Employee Stock Purchase Plan (ESPP).

• Tuition reimbursement program.