Clinical Trials Manager - Neurology

StrokeNet Thrombectomy Endovascular Platform (STEP) is a unique, first-of-its-kind platform trial that is looking at various treatments for patients with an Acute Stroke. The Clinical Trials Manager will oversee several aspects of national project management for this unique clinical trial. The Clinical Trials Manager will work directly with performance sites in the clinical trial. The appropriate candidate should have a clinical background and extensive clinical research experience.

• Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines
• Prepare, oversee, and review documents that are related to the assigned clinical study
• Arrange or help in organizing clinical study meetings
• Ensure the availability of necessary resources for the execution of clinical projects
• Help develop training materials and train clinical staff at sites
• Communicate with sites regarding key study updates during study webinars and other avenues
• Lead the clinical project team and various study team meetings
• Fully involved in resolving issues; take part in procedure improvement initiatives
• Attain clinical study goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
• Work hand-in-hand with the study team to manage documents that are related to the clinical study
• Responsible for maintaining the protocol versions and manual of procedures for the trial
• Help prepare safety reports in collaboration with clinical leaders of the project and sites
• Work collaboratively with team members to ensure regulatory compliance
• Perform related duties based on departmental need. 

• Bachelor's degree in nursing, Biology, and Public Health or related scientific/health field, Masters preferred.
• 6+ years of experience managing clinical trials, including 2 years in a management/leadership role; 9 years of experience highly preferred

• Additional Preferred Qualifications:

  • Possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external people like vendors and external consultants
  • Good problem-solving, organizational, and leadership skills are highly required
  • Ability to work with little or no supervision
  • Ability to pay keen attention to detail at all times
  • Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
  • Must be able to work as part of a team or in most cases lead a team
  • Must have a ‘one of a kind’ work ethic, and must exhibit a great level of self-discipline
  • Ability to organize and motivate other members of the study team
  • Proficient user of basic computer applications for the execution of daily project operations
  • Experience in writing clinical study procedures and other clinical documents is a plus

  • Experience in an academic or clinical setting in the area of clinical specialization

  • SoCRA and/or ACRP certification