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Clinical Job USA | Senior TMF Lead Position @ ICON

Clinical Job USA | Senior TMF Lead Position @ ICON

Clinical Job USA | Senior TMF Lead Position @ ICON: ICON group focuses on patient-centred research, including health related quality of life, disease symptoms, treatment adherence and satisfaction. The group is respected globally for the quality and innovation of their applied qualitative and quantitative work. Much of their work involves COA endpoint/instrument selection and regulatory support; COA instrument development and psychometric validation; study design, analysis and interpretation; utility measurement. You will have experience of applied research, either qualitative or quantitative, in an academic or commercial environment. You will have experience of providing leadership and guidance to more junior staff members and of managing both projects and research teams, including day-to-day liaison with clients.

Clinical Job USA | Senior TMF Lead Position @ ICON

Overview of the role

  • developing and assisting with the implementation of TMF specifications
  • ensuring TMF specifications are in alignment with the program strategy and milestones,
  • serve as the point of contact for internal and external audits related to TMF processes and activities.
  • assist with responses to regulatory authorities with regard to documentation management activities for audits, questions, and issues.
  • review metrics established for performance, review data quality outputs and audit outputs to identify trends per study and across programs,
  • assist with the development of corrective action plans related to TMF findings.

Role Requirements 

  • Bachelor’s Degree is required along with a minimum of three years’ experience and understanding of clinical study start up requirements and activities.
  • Clinical Document Management and industry experience to understand the processes and documents required within the conduct of clinical trials.
  • Good organizational skills, the ability to manage multiple tasks and proven experience of high standards of attention to detail.
  • You will possess good written and verbal communication skills and have logical and critical thinking skills.
  • Competent computer skills – MS Outlook and Excel and experience with electronic document management systems preferred.

Job Posted date: 7 Sept,2016
Reference: 042590

Clinical Job USA | Senior TMF Lead Position @ ICON

View Original Notification and How to Apply : http://careers.iconplc.com/job/senior-tmf-lead-jobid-042590_2

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