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Clinical Trials Project Lead

Employer
Global Academy Jobs
Location
Canada
Closing date
Oct 10, 2016

Job Details

This position has an expected end date of one year from the date of hire and offers a comprehensive benefits package which can be viewed at: www.hrs.ualberta.ca.

The Canadian VIGOUR Centre (CVC) has an excellent maternity leave replacement opportunity for a dynamic individual interested in becoming part of our leading Academic Research Organization internationally recognized for excellence in the management of large-scale clinical trials (www.vigour.ualberta.ca).   

We are currently accepting applications for a Clinical Trials Project Lead to develop, implement, manage and evaluate research and administrative strategies essential to the successful conduct of clinical trial projects by the Canadian VIGOUR Centre (CVC) in the Department of Medicine at the University of Alberta. This position will provide team leadership to project teams and research site personnel located at participating sites across Canada on one or multiple projects depending on size and scope.  The Clinical Trials Project Lead will assume responsibility for the overall operation, coordination and project management aspects of clinical projects and will serve as the primary contact with third parties for project related activities.

Duties

  • Oversees and is responsible for all aspects of the Clinical Trials Project(s) to ensure goals are achieved
  • Responsible for reporting Canadian trial status, metrics and performance to academic partners, sponsors, trial leadership and CVC leadership team
  • Acts as the day to day contact and resource for all participating clinical trial sites, sponsors, academic partners, CROs and monitors as it pertains to the operations of the trial in Canada
  • Coordinates detailed implementation plans and evaluation strategies for the project
  • Organizes, analyzes and communicates Clinical Trials Project information
  • Assists in the preparation and negotiation of financial contracts for clinical trial sites
  • In conjunction with the National Director, identifies, evaluates and recruits research sites through telephone screening interviews and site questionnaires
  • Supervises data management processes; reviews data, generates data queries as required and works with sites to ensure clean data is maintained
  • Assists in the development and maintenance of CVC and/or third party project-specific databases to provide project status reports, historical data and fulfill regulatory requirements
  • Distributes, collects, reviews, approves and ensures all ongoing required regulatory documentation from clinical trial sites
  • Responsible for all operational trial communications  with regulatory agencies, sponsor(s), external partners, monitors and clinical sites to assist in the ongoing monitoring and evaluation of the project and appropriately documents all communications
  • Analyzes identified issues as they arise and provides effective solutions for the project; appropriately escalates issues within the project
  • Mentors project team in all aspects of trial management including, but not limited to, ensuring from a regulatory perspective the trial is audit ready at all times, regulatory, training and files are current, relevant metrics are maintained and support is provided for data management and site contract negotiation/completion as needed


Qualifications

  • Minimum undergraduate degree in health, nursing and/or related field; advanced degree and/or completion of additional clinical research education is preferred 
  • Minimum five years of relevant clinical trial experience preferred
  • In-depth knowledge of clinical trial and drug development processes and regulatory requirements, site monitoring and project coordination
  • Experience in clinical trial databases
  • Proficiency with computers, office software and Internet technologies
  • Demonstrated ability to manage multiple projects and cross-functional teams
  • Demonstrated project leadership, analytical and problem-solving abilities
  • Excellent written, verbal and interpersonal communication skills

Company

Global Academy Jobs works with over 250 universities worldwide to promote academic mobility and international research collaboration. Global problems need international solutions. Our jobs board and emails reach the academics and researchers who can help.

"The globalisation of higher education continues apace, driving in turn the ongoing development of the global knowledge economy, striving for solutions to the world’s problems and educating a next generation of leaders and contributors."

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