Clinical Trial Site Operations Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and provide operational support for various clinical research sites within the network.

• Track site performance metrics such as enrollment, retention, protocol adherence, data quality, query resolution, and study timelines.

• Ensure the uniform application of SOPs, operational workflows, and best practices across all designated sites.

• Identify areas of operational deficiency and introduce process improvement initiatives to boost efficiency and site performance.

• Assist with study startup tasks, including feasibility assessments, site activation, staffing preparedness, staff training, and coordination with sponsors/CROs.

• Collaborate with site leadership to enhance resource allocation, staffing coverage, and workflow management.

• Ensure compliance with GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.

• Aid in ensuring audit readiness and support sponsor, CRO, and regulatory inspections/audits.

• Monitor protocol deviations, CAPAs, and quality-related matters, collaborating with site teams on corrective measures.

• Foster a culture of compliance, quality, and patient safety throughout the site network.

• Act as a primary operational liaison for PIs, Sub-Is, CRCs, and site personnel.

• Offer mentorship, coaching, and operational advice to clinical research staff.

• Assist in onboarding, training, and the continual development of site personnel.

• Promote strong collaboration and communication among cross-functional teams and site locations.

• Track and report on crucial operational and financial metrics across assigned sites.

• Support the attainment of enrollment goals, study milestones, and organizational growth strategies.

• Work with leadership on strategic initiatives, expansion prospects, and operational scaling efforts.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Healthcare Administration, Business Administration, or a related field is preferred.

• A minimum of 5 years of clinical research experience is required.

• Preferred: At least 2 years of experience in multi-site operational leadership or management.

• Strong understanding of GCP, FDA regulations, ICH guidelines, and clinical trial operations.

• Experience collaborating with Sponsors, CROs, PIs, and site networks.

• Proven ability to manage multiple priorities across various locations.

• Excellent leadership, communication, organizational, and problem-solving abilities.

• Proficient in CTMS, IRT, EDC systems, Microsoft Office, and clinical research technology platforms.

• Highly preferred: Experience within a multi-site clinical research network or SMO environment.

• Therapeutic area experience in fields like CNS, cardiology, metabolic, oncology, or vaccine studies.

• Experience in supporting audit readiness and regulatory inspections.

• Previous experience leading operational improvement initiatives and scaling research operations.

🏝️ Benefits

• Remote position with regular travel to assigned research sites as necessary.

• Potential to travel up to 30%.