We are conducting a confidential search for a Director of Clinical Operations to lead clinical trial execution for a life sciences organization based in Raleigh, working hybrid. This is a director-level opportunity for a clinical operations leader who can own trial delivery across multiple concurrent studies from site activation through database lock.
In this role, you will oversee end-to-end clinical trial management across Phase I-III studies, lead and manage CRO and vendor oversight including scope, budget, and performance against timelines, and ensure trials are conducted in compliance with GCP, ICH guidelines, and applicable regulatory requirements. You will drive site activation, patient recruitment, and enrollment strategies, manage clinical trial budgets and forecasts, and lead risk-based monitoring and quality oversight across the trial portfolio.
You will build and lead a team of clinical trial managers and CRAs, partner with regulatory affairs, biostatistics, and data management on trial deliverables, and represent clinical operations in interactions with investigators, IRBs/ethics committees, and regulatory authorities. You will also drive continuous improvement in trial execution processes and inspection readiness.
Nice to Have:
Experience managing global, multi-site clinical trials
Background in a specific therapeutic area relevant to the sponsor's pipeline
Experience with risk-based monitoring (RBM) and decentralized trial models
Direct experience with FDA inspections or regulatory audits
Certification in clinical research (CCRP, ACRP, or equivalent)
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