CRA Manager - Cell Therapy

Are you ready to lead a high-performing team that accelerates pivotal clinical trials and gets transformative medicines to patients faster? As CRA Manager within US Site Management and Monitoring, you will direct a group of Clinical Research Associates to deliver robust site performance, first-time quality, and on-time execution across a dynamic portfolio. Your leadership will ensure we meet the highest scientific and regulatory standards while keeping patient outcomes at the center.

You will shape how we deploy monitoring expertise, optimize resources, and strengthen site relationships across multiple indications. In this role, you will translate strategy into action—coaching, removing barriers, and making data-driven decisions that shorten timelines and elevate quality. Can you create clarity amid shifting priorities and bring out the best in a distributed team? If so, this is your opportunity to leave a measurable mark on an ambitious pipeline.

People leadership and development:
Provide day-to-day line management for a cohort of CRAs, setting clear expectations and delivering ongoing coaching, mentoring, performance reviews, and talent development to build future leaders

Hiring and onboarding:
Interview, hire, and train staff on SOPs, policies, and procedures, establishing a strong foundation in ICH/GCP and company practices

Resource and portfolio planning:
Evaluate and project resource needs based on the evolving portfolio; allocate CRAs efficiently to maximize site coverage, reduce bottlenecks, and protect milestones

Study delivery and oversight:
Ensure adequate, timely, and compliant monitoring, site management, and oversight for assigned CRAs to drive high-quality execution and audit readiness

Cross-functional collaboration:

Build close working relationships with other CRA Managers, Clinical Research Managers, and key internal and external stakeholders to align on priorities and resolve issues quickly

Quality coaching and field engagement:
Conduct quality visits with each employee CRA twice annually; use insights to enhance monitoring quality, consistency, and risk-based focus

Transparent communication:
Keep staff informed on program and policy changes, and priority shifts; cascade information promptly to sustain alignment and pace

Issue escalation and resolution:
Stay attuned to workload and efficiency challenges; collaborate with peers and US leadership to elevate and resolve issues so teams stay focused on delivery

Financial stewardship:
Review and approve expenses; ensure timely, compliant expense submissions aligned to company policy and budget discipline

Leadership presence and cadence:
Lead regular staff meetings and actively participate in management forums to share insights, reinforce strategy, and drive continuous improvement

Strategic initiatives and best practice:
Lead special initiatives that improve trial execution, standardize practices, and scale learnings across teams

Site partnerships and capability building:
Partner with priority operational sites to strengthen relationships and accelerate study starts and enrollment; contribute to training and mentoring of new Study Delivery Team members

Process optimization and knowledge sharing:
Champion more efficient methods and digital tools that enhance monitoring quality, reduce cycle times, and strengthen data integrity.

• University degree in related discipline, preferably in life science, or equivalent qualification
• 8 years of clinical trial experience with at least 4 years of site monitoring
• Study leadership and/or line management preferred
• Fluent knowledge of spoken and written English
• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP
• Good knowledge of relevant local regulations
• Good medical knowledge in relevant AZ Therapeutic Areas
• Basic understanding of the drug development process
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management
• Ability to travel is required, approximately 15%.

• Ability to deliver quality according to the requested standards
• Ability to work in an environment of…