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.
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