Clinical Operations Regional Lead
Regional Lead, Clinical Operations (Oncology - Early Phase Trials)
Location: Flexible
A leading biotech company focused on precision oncology is seeking a Regional Lead of Clinical Operations to join their dynamic team. This is a unique opportunity to play a pivotal role in the execution of early-stage clinical trials and help shape the future of cancer treatment.
About the Role:
As a Regional Lead, you will oversee the operational execution of one or more clinical trials from start-up through close-out. You'll collaborate cross-functionally with internal teams and external partners to ensure trials are delivered on time, within budget, and in compliance with global regulatory standards.
Key Responsibilities:
- Support Study Leads and cross-functional Study Execution Teams (SETs) in trial planning and execution.
- Manage CROs and clinical vendors, including RFPs, bid defenses, and contract oversight.
- Contribute to the development and review of clinical documents (protocols, ICFs, CRFs, study manuals).
- Oversee clinical systems (CTMS, TMF, EDC, IRT) and ensure inspection readiness.
- Conduct clinical data review and site management in collaboration with CROs.
- Monitor study metrics, identify risks, and implement mitigation strategies.
- Foster strong relationships with investigators, site staff, and internal stakeholders.
- Participate in audits and regulatory inspections as needed.
Qualifications:
- Bachelor's degree in life sciences or related field.
- 6+ years of experience in clinical operations and drug development.
- Strong knowledge of FDA, ICH/GCP regulations, and global clinical trial management.
- Experience in early-phase oncology trials, including precision medicine, is preferred.
- Excellent organizational, analytical, and communication skills.
- Proactive, detail-oriented, and a collaborative team player.
- Willingness to travel up to 20 percent.
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