CRA Manager - Cell Therapy

AstraZeneca; Wilmington (DE); On-site; USD 138,000 - 207,000; Full time

Benefits offered by this job

Retirement plan

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca in Wilmington, DE, seeks a CRA Manager to lead a high-performing team of Clinical Research Associates, delivering site performance, first-time quality, and on-time execution across a dynamic portfolio.

You will coach, allocate resources, and drive data-driven decisions to shorten timelines, ensure compliance with ICH/GCP, and strengthen site relationships in multiple indications. Travel approx 15% is required.

Qualifications

• University degree 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 ICH/GCP, basic GMP/GDP.
• Good knowledge of local regulations.
• Good medical knowledge in AZ Therapeutic Areas.
• Understanding of the drug development process.
• Understanding of Clinical Study Management including monitoring and data management.
• Ability to travel ~15%.

Responsibilities

• Provide day-to-day line management for CRAs, including coaching, performance reviews, and talent development.
• Interview, hire, and train staff on SOPs and company practices.
• Plan resources to maximize site coverage and protect milestones.
• Ensure timely, compliant monitoring and oversight for CRAs.
• Build relationships with stakeholders to align priorities and resolve issues quickly.
• Conduct quality visits and use insights to improve monitoring quality and risk focus.
• Communicate program changes and keep teams aligned.
• Escalate and resolve workload and efficiency challenges with leadership.
• Review and approve expenses per policy and budget.
• Lead staff meetings and participate in management forums.
• Drive strategic initiatives to improve trial execution and data integrity.
• Partner with sites to strengthen relationships and accelerate starts.
• Champion efficient methods and digital tools for better quality and speed.

Skills

People leadership

Coaching & mentoring

Fluent English

ICH/GCP knowledge

Global/regulatory knowledge

Education

Life science degree

Job description

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.

Accountabilities

• 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.

Essential Skills/Experience

• 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%

Desirable Skills/Experience

• Ability to deliver quality according to the requested standards
• Ability to work in an environment of remote collaborators
• Manages change with a positive approach for self, team and the business
• Sees change as an opportunity to improve performance and add value to the business
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
• Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
• Good analytical and problem-solving skills
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
• Good cultural awareness
• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

The annual base pay for this position ranges from $137,937.60 - $206,906.40. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.

Benefits offered include

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Here, curiosity drives decisions and evidence shapes action. You will join a community that unites scientific rigor with advanced technology to turn promising molecules into medicines that can reshape standards of care, particularly in oncology. We bring unexpected teams together to solve hard problems, publish at the highest levels, and invest deeply in research so ideas can move quickly from concept to clinic. You will be trusted to lead, encouraged to question, and supported by colleagues who value kindness alongside ambition—so your leadership has impact on both your team and patients who need new options.

Date Posted

13-Aug-2026

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.