Clinical Trial Operations Consultant
Location: Naperville, Illinois, USA
Employment Type: Full-Time
About the Role
We are seeking an experienced Clinical Trial Operations Consultant to provide strategic and operational support across global clinical trials. This role is ideal for professionals with expertise in clinical trial planning, execution, and oversight, coupled with strong project management skills and cross-functional collaboration experience. You will ensure operational excellence, regulatory compliance, and timely delivery of milestones for Phase I-IV studies across therapeutic areas.
Key Responsibilities
Lead and manage end-to-end execution of clinical trials, including study planning, start-up, conduct, and close-out activities.
Collaborate with cross-functional teams such as Regulatory, Medical Affairs, Data Management, Quality, and Safety 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 resolve operational or study-related issues to maintain quality and compliance.
Oversee vendor selection, contract negotiations, and performance management for CROs, laboratories, and eClinical vendors.
Ensure trial conduct complies with ICH-GCP guidelines, FDA/EMA regulations, and organizational SOPs.
Support preparation of study documents including protocols, investigator brochures, informed consent forms (ICFs), study plans, and regulatory submissions.
Conduct feasibility assessments, site qualification, and site initiation activities.
Provide leadership, guidance, and mentorship to study teams, CRAs, and site monitors where applicable.
Contribute to process improvement initiatives and development of clinical operations best practices.
Experience and Skills Required
Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or related field.
Minimum 7 years of experience in clinical trial operations, with at least 3 years in project/study management.
Proven experience managing complex, global clinical studies across multiple therapeutic areas.
Strong knowledge of ICH-GCP guidelines, FDA/EMA regulations, and industry best practices.
Hands-on experience with CTMS, EDC, eTMF, and other eClinical platforms.
Excellent organizational, analytical, and problem-solving skills.
Strong interpersonal and communication skills, with the ability to influence cross-functional teams and vendors.
PMP or equivalent project management certification is a plus.
Experience in fast-paced, entrepreneurial, or consulting environments is preferred.
Why Join Us
Contribute to innovative global clinical research programs.
Work with passionate professionals advancing healthcare worldwide.
Flexible work arrangements in a collaborative and growth-focused culture.
Engage in meaningful work that drives clinical trial efficiency and compliance.
How to Apply
Apply today to join a global team as a Clinical Trial Operations Consultant and play a key role in delivering high-quality, compliant clinical studies across the world.
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