Manager Clinical Research Business and Regulatory Operations job at reputed company in Akron, OH

Title: Manager Clinical Research Business and Regulatory Operations Location: Akron reputed company Research | Full Time Job reputed company: Full-time, 40 hours/week Monday- Friday reputed company-5pm Hybrid remote, 3 days/week onsite reputed company: 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-reputed company 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: reputed company development, negotiation, and management of clinical trial budgets, financial tracking, and variance analysis. Monitor reputed company, expenses, and contract alignment to ensure fiscal accuracy and financial sustainability. reputed company CTMS administration, configuration, optimization, and integration with financial and regulatory workflows. reputed company and enforce CTMS governance standards, data reputed company processes, and user training programs. reputed company regulatory documentation workflows, ensuring high‑reputed company preparation, submission, and maintenance of essential documents. Ensure compliance with federal regulations, ICH GCP, institutional policies, and sponsor requirements. Manage IRB submissions, amendments, continuing reviews, safety reporting, and document control processes. reputed company cross‑functional coordination between clinical operations, regulatory teams, finance, investigators, and leadership. Drive process improvement initiatives and reputed company SOPs, work instructions, and training materials. Promote reputed company, compliance, audit readiness, and operational transparency by monitoring KPIs and guiding corrective actions. Other information: Technical Expertise Demonstrated experience with CTMS platforms (preferably ENCOR) and clinical trial budgeting. Strong knowledge of GCP, FDA regulations, and institutional research requirements. Leadership experience with the ability to supervise, mentor, and reputed company staff. Excellent analytical, organizational, and communication skills. Education and Experience Education Bachelor of Science, reputed company, finance or reputed company field or 10 years relevant experience, Master's degree preferred. Licensure: NA Certification: NA Years of relevant experience: minimum 5 years of experience in clinical research operations, regulatory affairs, research finance, or reputed company areas. Years of supervisory experience Minimum 2 years Full Time FTE: 1.000000 Status: Fixed Hybrid Apply tot his job Apply To this Job