Director of Clinical Operations

CONFIDENTIAL Scovai; Raleigh; Híbrido; CAD 252.000 - 350.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Descripción de la vacante

Scovai in Raleigh is seeking a Director of Clinical Operations to lead trial execution for Phase I–III studies across multiple sites, from site activation to database lock, in a hybrid work environment.

You will oversee end-to-end management, CRO/vendor oversight, budgets and timelines, and ensure compliance with GCP and ICH. You will build and lead a team of CTMs/CRAs and collaborate with regulatory, biostatistics, and data management to drive continuous improvement and inspection readiness.

Responsabilidades

• Lead end-to-end clinical trial management for Phase I–III across multiple sites.
• Oversee CRO and vendor oversight including scope, budget, and timelines.
• Ensure trials comply with GCP, ICH guidelines and regulatory requirements.
• Drive site activation, patient recruitment and enrollment strategies.
• Manage trial budgets and forecasts; monitor spend and forecast accuracy.
• Lead risk-based monitoring and quality oversight across the trial portfolio.
• Build and lead a team of CTMs and CRAs; mentor staff.
• Partner with Regulatory Affairs, Biostatistics, and Data Management on deliverables.
• Represent operations in interactions with investigators, IRBs, and regulators.
• Drive continuous improvement and inspection readiness.

Conocimientos

Leadership

Clinical operations

Budget management

Regulatory compliance

RBM

Site activation

Descripción del empleo

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)