Career Center

Full-time, 40 hours/week
Monday- Friday 8am-5pm

Hybrid remote, 3 days/week onsite

Summary:

The Manager, Clinical Research Business & Regulatory Operations provides strategic and operational leadership across the financial, regulatory, and systems infrastructure that supports clinical research. This role oversees clinical trial budgeting and fiscal stewardship, manages the Clinical Trial Management System (CTMS) governance and optimization, and directs regulatory documentation workflows to ensure compliance, efficiency, and high-quality execution of research activities. The manager serves as a central operational hub, aligning business processes, regulatory standards, and system functionality to support a high performing clinical research portfolio.

Responsibilities:

1. Lead development, negotiation, and management of clinical trial budgets, financial tracking, and variance analysis.
2. Monitor revenue, expenses, and contract alignment to ensure fiscal accuracy and financial sustainability.
3. Oversee CTMS administration, configuration, optimization, and integration with financial and regulatory workflows.
4. Develop and enforce CTMS governance standards, data quality processes, and user training programs.
5. Direct regulatory documentation workflows, ensuring high?quality preparation, submission, and maintenance of essential documents.
6. Ensure compliance with federal regulations, ICH GCP, institutional policies, and sponsor requirements.
7. Manage IRB submissions, amendments, continuing reviews, safety reporting, and document control processes.
8. Lead cross?functional coordination between clinical operations, regulatory teams, finance, investigators, and leadership.
9. Drive process improvement initiatives and develop SOPs, work instructions, and training materials.
10. Promote quality, compliance, audit readiness, and operational transparency by monitoring KPIs and guiding corrective actions.

Other information:

Technical Expertise

Full Time

FTE: 1.000000

Status: Fixed Hybrid

About Akron Children's

More Than a Job. It’s loving what you do - and why you do it. Akron Children’s Hospital is ranked among the best pediatric hospitals by U.S. News & World Report, but it’s our compassionate approach to treatment that sets us apart. It’s creating special high-fives. Thinking of new ways to spark a smile. Holding hands to offer comfort. And working to get a giggle that brightens a room. The minute you walk into Akron Children’s, you can sense that people here love what they do. From visits with the Doggie Brigade, to the balloons and smiles in the halls, the sights and sounds are all about one thing: the children. We are the largest pediatric healthcare system in Northern Ohio and one of the fastest growing in the country. Akron Children’s has two hospital campuses in Northeast Ohio: one in Akron and the other in Boardman in the Mahoning Valley. With two hospital campuses, regional health centers and more than 50 primary and specialty care locations throughout Ohio, we’re making it easier for today’s busy families - regardless of where they live - to find the high-quality care they need. No matter which of our locations you choose, you’ll see that when you give the most, you get more—...support, rewards and satisfaction. CAREER OPPORTUNITIES: It’s making the most of your days. Our passion is felt every day in the way people care at every level. Whether you are working with children face-to-face, or behind the scenes supporting the care and services we deliver, you impact futures. Visit us and see why it’s more than just a place to work. It’s a family. Apply today at careers.akronchildrens.org.

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