Operations Manager Clinical Trials

CAREERXCHANGE, Inc.

Miami, FL

JOB DETAILS
SALARY
$41–$56 Per Hour
SKILLS
Analysis Skills, Biology, Budget Management, Clinical Information Systems, Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Cross-Functional, Data Quality, Documentation, FDA Requirements, GCP (Good Clinical Practices), Healthcare Administration, Healthcare Quality, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Leadership, Maintain Compliance, Multitasking, Nursing Administration, Operational Improvement, Operations Management, Operations Planning, Operations Processes, Operations Research, Organizational Skills, Process Improvement, Project/Program Management, Public Health, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Research Protocols, Resource Management
LOCATION
Miami, FL
POSTED
20 days ago
Location: Miami, FL
Job Type: Temporary Contract (15 Weeks)
Schedule: Monday – Friday | 8:30 AM – 5:00 PM
Pay: $41.00 – $56.00 per hour


Job Summary
We are seeking an experienced Clinical Trials Operations Manager to support a leading clinical research program during a 15-week contract assignment. This role is responsible for overseeing the operational execution of clinical trials, ensuring compliance with regulatory requirements, optimizing research processes, and supporting cross-functional teams to deliver high-quality clinical research.
The ideal candidate has strong leadership skills, experience managing clinical trial operations, and a thorough understanding of FDA regulations, Good Clinical Practice (GCP), and clinical research workflows.


Responsibilities
  • Oversee the day-to-day operations of multiple clinical research studies.
  • Lead and support clinical research staff, ensuring adherence to study protocols and timelines.
  • Collaborate with investigators, research coordinators, regulatory teams, sponsors, and study monitors.
  • Monitor study progress, enrollment, and operational performance to ensure milestones are met.
  • Ensure compliance with FDA regulations, Good Clinical Practice (GCP), IRB requirements, and sponsor guidelines.
  • Develop and implement operational processes to improve efficiency and quality.
  • Oversee clinical trial budgets, resource allocation, and operational reporting.
  • Prepare for sponsor visits, monitoring visits, audits, and regulatory inspections.
  • Identify operational challenges and implement effective solutions.
  • Maintain accurate documentation and ensure data integrity throughout the clinical trial lifecycle.

Qualifications
  • Bachelor's degree in Life Sciences, Healthcare Administration, Nursing, Public Health, or a related field required; Master's degree preferred.
  • Minimum of 5 years of experience in clinical research operations or clinical trial management.
  • Previous leadership or management experience within a clinical research environment.
  • Strong knowledge of FDA regulations, ICH-GCP guidelines, IRB processes, and clinical trial operations.
  • Experience working with Clinical Trial Management Systems (CTMS) and electronic research platforms.
  • Excellent organizational, analytical, and project management skills.
  • Strong communication and leadership abilities with the ability to manage multiple priorities in a fast-paced environment.

CAREERXCHANGE, INC is an EOE.  Visit our website www.careerxchange.com to view other job opportunities.


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About the Company

C

CAREERXCHANGE, Inc.