Clinical Trial Operations Specialist

Essential Functions

• 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).
• Cook up logistics for trial meetings, materials, and supplies.
• Coordinate with 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.

Qualifications

• University degree qualified and/or comparable professional education with at least 3+ 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.
• Fully fluent in written and spoken English.

Pay

The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).