Clinical Trial Operations Specialist
IQVIA•Durham, NC
•$68,400 - $171,000•Remote
About The Position
Provide operational support and coordination for global clinical trials, ensuring efficient trial execution from planning through close-out. Responsible for managing trial-related documentation, systems, communication, and logistics in compliance with SOPs, ICH-GCP, and regulatory requirements, while meeting quality and timeline objectives.
Requirements
- University degree qualified and/or comparable professional education with at least 5 years’ experience in clinical trial operations or project coordination.
- Exceptional communication and stakeholder management skills.
- Strong knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Excellent organizational and problem-solving skills with ability to work independently, prioritize tasks, and manage projects in a complex international environment.
- Detail-oriented with strong commitment to quality and compliance.
- Proficiency in MS Office and clinical trial systems/tools.
- Fluent in written and spoken English.
Responsibilities
- Plan, coordinate, and execute clinical trial activities across regions in compliance with ICH-GCP, ensuring timely and high-quality delivery.
- Maintain and oversee trial documentation (e.g., ISF, TMF, submissions), ensuring completeness, accuracy, timeliness and audit readiness.
- Collaborate with global and regional stakeholders, vendors, and trial teams to ensure seamless trial conduct and communication.
- Manage and maintain clinical trial systems, databases, and tracking tools ensuring data accuracy.
- Prepare and distribute project plans, status updates, reports, and presentation materials.
- Monitor trial progress, budgets, and system data, identifying risks and implementing corrective actions as needed.
- Coordinate documentation workflows, regulatory submissions, and communication with authorities and regional teams.
- Support reporting, trial close-out activities, and preparation of key deliverables (e.g., CTR appendices).
- Coordinate logistics for trial meetings, materials, and supplies.
- Contribute to quality oversight, inspection readiness, and best practices in clinical trial conduct.
- Act as a key point of contact for trial-related systems, documentation, and operational queries.
Benefits
- Potential base pay range of $68,400.00 - $171,000.00 annually.
- Incentive plans, bonuses, and/or other forms of compensation may be offered.
- A range of health and welfare and/or other benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
