Clinical Trial Manager

 

 
 

About the Position

The ARC is looking for a motivated, compassionate, and innovative Clinical Trial Manager to manage the day to day operations of its clinical trials. This role is critical to the ARC’s ability to deliver high quality clinical research that will help accelerate drug development in amyloidosis. The ARC seeks candidates who have experience managing industry and investigator sponsored clinical trials, and who bring a well-developed skill set of prioritizing, focusing, and executing.

The Clinical Trial Manager will be responsible for the day to day management of ARC clinical trials. This position will work closely with multiple stakeholders, including KOLs, clinical sites, CROs, and industry sponsors, to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/Good Clinical Practice (GCP)/regulatory guidelines, organization goals, and budgets. This position is responsible for ensuring achievement of own or others’ project goals and objectives.  This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates.


Key Responsibilities: 

  • Manages the operational aspects of clinical trials
  • Participates in protocol, informed consent, CRF development, Clinical Study Report preparation, as appropriate
  • Prepares metrics and updates for management, as assigned
  • Manages program and study timelines and budgets
  • Proactively identifies potential issues/risks and recommends/implements solutions
  • Participates in and facilitates CRO/vendor selection process for outsourced activities
  • Manages CRO/vendor interactions, providing sponsor oversight of operational activities (e.g., study management, monitoring, site management, project master files), develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Prepares and/or reviews/approves study-related documents as appropriate (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines), and site-related study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
  • Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regional/country specific regulations
  • Organizes and manages study management team meetings, investigator meetings and other trial-specific meetings as required
  • Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
  • Participates in the development, review and implementation of SOPs, processes, templates and tools

Key Qualifications

  • Bachelor degree in a science or health related field required
  • 5+ years of relevant industry experience, with at least 3 years of direct clinical trial management experience at a Sponsor/Company or CRO
  • Industry experience overseeing ISTs is a plus
  • Proven ability to provide clinical expertise to a clinical development program in a specified product area with experience in managing CROs, specialty labs, outside vendors and international trials
  • Familiar with advanced concepts of clinical research with demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA and Country regulations/ICH guidelines, is required
  • High degree of customer focus towards internal and external stakeholders; strong collaboration skills, excellent planning skills and able to manage multiple projects with time demands
  • Genuine interest and commitment to the ARC mission, with the ability to effectively communicate it
  • 10-20% travel may be required

Please email your cover letter and resume in confidence to:  research@arci.org

All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, or any other characteristic protected by law.