Job Type: Contract
Contract Length: 6–12+ months (potential extension)
Pay Range: $70–$90/hr
Start Date: ASAP
Location: Remote/Hybrid (Travel approximately 15%)
About the Opportunity:
Our client, a leader in the pharmaceutical industry, is seeking a skilled Clinical Trial Manager (CTM) to join their team for a 6–12+ month engagement. This high-impact role supports Phase I-III oncology studies, focusing on end-to-end study execution, CRO and vendor oversight, and clinical operations leadership. This role is ideal for a hands-on professional who can independently manage complex studies, proactively mitigate operational risks, and serve as a key partner to internal stakeholders.
Key Responsibilities & Deliverables:
This role is focused on the successful completion of study operations and deliverables. Your responsibilities will include:
- Study Execution & Oversight: Manage one or more Phase I-III clinical studies or major components with limited supervision, ensuring quality, timelines, and deliverables are met.
- Vendor Management: Oversee CROs and ancillary vendors throughout the study lifecycle.
- Study Startup: Drive site activation, enrollment readiness, and startup activities.
- Operational Leadership: Analyze enrollment and operational metrics to provide data-driven recommendations to study leadership.
- Compliance & Inspection Readiness: Lead TMF reconciliation and inspection readiness activities, ensuring strict adherence to FDA, EMA, and ICH-GCP regulations.
- Collaboration: Lead cross-functional study meetings, review protocols, ICFs, CRFs, and monitoring plans, and support data surveillance to identify and resolve discrepancies.
- Mentorship: Support team development by mentoring CTAs and CTMAs.
We are looking for someone with a proven track record of successful clinical operations management. The ideal candidate will have:
- 5–7+ years of experience in pharmaceutical, biotech, or clinical research operations.
- Demonstrated experience with independent study ownership in a CTM capacity.
- Strong oncology experience (early-phase experience is preferred).
- Deep expertise in Phase I-III clinical trial execution, site startup, and CRO/vendor management.
- Hands-on experience with eTMF, EDC, IRT, and CTMS systems.
- BS, BA, or RN in a scientific or healthcare-related discipline.
- Strong communication and project management skills, with the ability to prioritize effectively in a fast-paced, complex environment.
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