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Sr Mgr, Clinical Trial Mgmnt - CNS/Rare Diseases

JR065237

About the role

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ICON is seeking a Sr. Manager, Clinical Trial Management for our CNS/Rare Diseases 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.
  • Implement QC activities, ensure compliance with quality measures and monitor required quality metrics.
Requirements:
  • Track record of successful management of the Clinical Operations aspects of regional/global studies/programs
  • A minimum of five (5) years of clinical research experience with at least three (3) years of clinical trial management experience
  • Strong leadership skills, prior successful experience in mentoring CTMs, demonstrated project management ability as well as a positive approach in managing staff, clients and project related issues are necessary to perform successfully in a service-oriented environment.
  • Proven track record in successfully managing change.
  • Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
  • Fluent in written and spoken English.
  • Computer literate.
  • Ability and willingness to travel approximately 20% of the time (international and domestic; fly and drive).
  • Extensive use of telephone expected
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