Job Title: Contractor, Clinical Trial Management (6-month temp-to-perm)
Salary: $120,000 - $180,000
Location: Remote/Hybrid/Onsite, Irvine, CA
Job Summary:
Oversee day-to-day operations and management for clinical and regulatory projects to achieve strategic pipeline milestones. Responsibilities include managing drug development activities, supporting program execution, and maintaining regulatory compliance with GCP, FDA, ICH, and internal SOP standards.
Key Responsibilities
1. Clinical Trial Operations & Study Execution
- Project Management & Execution: Oversee day-to-day clinical trial operations to ensure study activities align with corporate goals, milestones, and timeline deliverables.
- Documentation & Regulatory Compliance: Author, review, and contribute to critical study documents, including protocols, ICFs, CRFs, study plans/manuals, Investigator’s Brochures (IBs), and Clinical Study Reports (CSRs).
- Trial Master File (TMF) & Quality Standards: Ensure ongoing TMF completeness, data integrity, regulatory compliance, and audit readiness across all assigned studies.
- Site & Investigator Oversight: Monitor investigator site performance, trial enrollment, and protocol adherence to maintain study quality standards.
2. Vendor & CRO Management
- Vendor Operations: Lead vendor selection and oversight, including reviewing proposals/RFPs, evaluating technical specs, and managing CRO/vendor performance against contractual timelines, quality, and deliverables.
- Budget & Financial Control: Manage study budgets with close financial oversight, accurate forecasting, and active monitoring of vendor invoicing and spend.
3. Cross-Functional Leadership & Governance
- Governance & Alignment: Drive cross-functional team meetings by preparing agendas, documenting action items, tracking metrics, and facilitating seamless communication between internal teams and external stakeholders.
- Strategic Initiatives: Autonomously lead and execute cross-functional strategic operational initiatives with minimal supervision.
- Reporting & Executive Presentations: Compile operational metrics and prepare high-level progress reports and presentations for executive leadership.
4. Risk Management & Problem Resolution
- Proactive Mitigation: Identify operational and clinical trial risks early, develop targeted response strategies, and drive effective problem resolution.
- Issue Escalation: Timely escalate critical issues and systemic operational risks to senior leadership with actionable mitigation plans.
5. Additional tasks and special projects may be assigned by leadership.
Technology & System Requirements
The ideal candidate should be highly proficient with technology and have a higher-than-average level of experience using the following:
- Microsoft Office Suite – Excel, Word, PowerPoint, Outlook (including advanced Excel functionalities such as pivot tables, and data analysis).
- Project & Workflow Management Tools – Smartsheet, Monday.com
- Electronic Data Capture (EDC) Systems – e.g., Medidata Rave
- Electronic Trial Master File (eTMF) Systems – e.g., Veeva Vault, Trial Interactive, or similar.
- Document Management Systems (DMS) – e.g., SharePoint, or similar.
- Virtual Meeting & Collaboration Tools – Must be comfortable being on video for remote meetings via Microsoft Teams, and other communication tools.
Education, Qualifications & Experience
- Master of Science (MS) degree in a scientific or life sciences discipline with 6+ years of relevant industry experience, or a Bachelor of Science (BS) degree with 10+ years of equivalent experience.
- Clinical Trial Management: Demonstrated hands-on experience managing clinical trials from initiation through closeout.
- Therapeutic Area Expertise: Proven background in Oncology or Cell Therapy drug development required.
- Vendor & Partner Oversight: Extensive experience directing and collaborating with external partners—including CROs, CDMOs, central labs, and consultants—as well as cross-functional internal teams.
- Regulatory Compliance: In-depth working knowledge of FDA regulations, ICH guidelines, and Good Clinical Practice (GCP) standards.
- Strong self-starter with the ability to take full ownership of assigned studies, drive execution, and deliver results under limited supervision.
- Thrives in a fast-paced, high-growth environment; adept at multi-tasking and dynamically adjusting priorities to meet shifting organizational goals.
- Outstanding interpersonal, written, and verbal communication skills with a proven track record of influencing stakeholders, driving accountability, and fostering cross-functional alignment.
- Willingness to occasionally work non-standard business hours to accommodate global, multi-site study operations.
Pay: $120,000.00 - $180,000.00 per year
Work Location: Hybrid remote in Irvine, CA 92618
