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IQVIA logo
IQVIA

Accelerate innovation for a healthier world.

Clinical Trial Operations Specialist

Clinical OperationsClinical OperationsFull TimeRemoteMid LevelTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

17 days ago

Salary

$68.4K - $171K / year

Seniority

Mid Level

No structured requirement data.

Job Description

Clinical Trial Operations Specialist

IQVIA

Role Description 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. - 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. Qualifications - 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. Benefits - 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). - Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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