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.
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.