Clinical Trial Operations Consultant

Backto Job Openings Clinical Trial Operations Consultant Location: Naperville, IL Job Type: Full-time Position Summary We are seeking an experienced Clinical Trial Operations Consultant to provide strategic and hands‑on support in the planning, execution, and oversight of clinical trials. The ideal candidate will possess strong project management skills, a deep understanding of clinical trial processes, and the ability to work cross‑functionally with internal teams and external partners. This role is critical in ensuring operational excellence, regulatory compliance, and timely delivery of milestones across global clinical studies. Key Responsibilities Lead and manage the end‑to‑end execution of clinical trials (Phase I‑IV), including study planning, start‑up, conduct, and close‑out activities. Collaborate with cross‑functional teams (Regulatory, Medical, Data Management, Quality, Safety, etc.) to align operational strategies with overall clinical development goals. Develop, implement, and maintain project plans, timelines, risk management strategies, and trial budgets. Monitor study performance metrics, track deliverables, and drive resolution of study issues to ensure quality and compliance. Oversee vendor selection, contract negotiations, and performance management (CROs, labs, eClinical vendors, etc.). Ensure trial conduct aligns with ICH‑GCP, regulatory requirements, and SOPs. Support the preparation of study documents, including protocols, investigator brochures, ICFs, study plans, and regulatory submissions. Conduct feasibility assessments, site qualification, and initiation activities. Provide leadership and mentorship to study teams, CRAs, and site monitors when applicable. Contribute to process improvement initiatives and the development of clinical operations best practices. Qualifications Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or related field. Minimum of 7+ years of experience in clinical trial operations and 3+ years in project/study management. Proven track record of managing complex, global clinical studies across multiple therapeutic areas. In‑depth knowledge of ICH‑GCP guidelines, FDA/EMA regulations, and industry best practices. Experience with clinical trial management systems (CTMS), electronic data capture (EDC), eTMF, and other eClinical tools. Strong organizational, analytical, and problem‑solving skills. Excellent interpersonal and communication skills, with the ability to influence cross‑functional teams and vendors. PMP or similar project management certification is a plus. Experience working in a fast‑paced, entrepreneurial environment or consulting role preferred. Why Join Us Engage with innovative and transformative clinical research programs. Work alongside passionate professionals committed to advancing healthcare. Flexible working arrangements and a collaborative, growth‑oriented culture. #J-18808-Ljbffr