ICON plc

Senior Clinical Trial Manager

ICON plc

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • As a Senior Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What you will be doing: Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial with a focus on late-stage trials Lead the Clinical Trial Team, and support other development teams as a Clinical Operations representative as required Perform and document study level Sponsor Oversight of outsourced clinical activities Communicate study-status, cost, and issues to ensure timely decision-making by senior management Initiate and manage study-level timelines, including communication to internal and external team members on deliverables Work closely with other supporting clinical operations team members to execute clinical studies Draft and/or oversee the drafting of site materials including training, manuals, and support documentation Review clinical data to ensure timely entry and readiness for data review meetings Perform periodic review of clinical data, quality metrics, and study deviations Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate Review clinical monitoring reports to ensure timely completion and identification of issues Complete and maintain internal clinical trial metrics, dashboards, and other internal updates Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities

Requirements

  • 5-7 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent trial management preferred Bachelor’s degree required; Advanced degree preferred Late-stage experience preferred Solid understanding of drug development Good project management skills Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies Excellent verbal and written communication skills Good organizational skills and attention to detail