ICON Clinical Research Sr. Manager, Clinical Trial Management - Internal Medicine (Home-based) in Boston, Massachusetts

ICON is seeking a Sr. Manager, Clinical Trial Management for our Internal Medicine team! This position can be home-based anywhere in the U.S.

Responsibilities:

  • To act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies.

  • To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study, for the delivery of all aspects of monitoring and site management

  • Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.

  • As a Sr. Manager, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs.

  • Actively identify opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices.

  • Travel (approximately 25%) domestic and/or international.

  • Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.

  • Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments, protocol deviation prevention, tracking and reporting; IP management, timely investigator payments.

  • Responsible for driving enrollment as per contracted timelines.

  • Regular oversight of key clinical metrics, including but not limited to: Days on Site (DOS), Monitoring Visit reports (MVR) and Follow up Letters (FUL) timelines, Action Items (Al) and other quality metrics.

  • Oversight of visit report review and approval, including site issue escalation and resolution.

  • Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner.

  • Contribute to the development and maintenance of all clinical elements of cross functional project plans.

  • Active involvement in clinical risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation and resolution.

  • Responsible for the development and maintenance of operational plans for clinical deliverables

  • Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP).

  • Ensure all close-out activities are completed as necessary e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved.

  • Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables.

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