Precision For Medicine

Manager, Global Clinical Monitoring

Precision For Medicine

full-time

Posted on:

Origin:  • 🇨🇦 Canada

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Salary

💰 $113,900 - $170,900 per year

Job Level

SeniorLead

Tech Stack

Google Cloud Platform

About the role

  • Manage and develop the organization’s Clinical Research Associate (CRA) workforce
  • Lead, manage, and motivate a team of CRAs (employee and/or consultant)
  • Ensure proper resource assignment and tools for project success
  • Generate action plans and provide developmental/strategic oversight to optimize CRA services
  • Assist with and contribute to project resourcing and update tracking systems
  • Collaborate with Clinical Team Leads/Managers and Clinical Operations Management Team
  • Perform accompanied site visits to assess CRA skills and developmental needs
  • Identify quality risks and recommend corrective actions
  • Ensure staff have proper resources, training, materials, and system access
  • Ensure timely and accurate administrative updates by CRAs
  • Improve CRA expectations and procedures to promote quality and efficiency
  • Develop and maintain metrics pertinent to CRA resource oversight
  • Participate in interviewing and onboarding training for new CRAs
  • Manage CRA staff in accordance with company values and policies
  • Secondary responsibilities: assist with planning, assigning, directing work, and gathering performance feedback

Requirements

  • Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
  • At least 7 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience
  • Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records
  • 3-5 years of direct supervisory experience managing CRAs
  • Experience creating effective development programs for clinical staff
  • Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained
  • Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%
  • Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant SOPs, technical CRA knowledge of all phases of study
  • High capacity for Emotional Intelligence and a passion for people management and development
  • Ability to develop training plans and hold personnel accountable
  • Understanding and ability to work with EMRs and EDCs
  • Strong communication and presentation skills
  • High self-motivation and ability to work independently and in teams
  • Highly organized with excellent problem-solving skills