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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