Precision Medicine Group

Manager, Global Clinical Monitoring

Precision Medicine Group

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 Clinical Research Associate (CRA) workforce and support departmental initiatives to strengthen quality and productivity of GCM operations
  • Independently lead, manage, and motivate a team of CRAs (employee and/or consultant) ensuring resources are assigned appropriately and provided necessary tools
  • Generate action plans and provide developmental/strategic oversight to optimize CRA services
  • Assist with and contribute to project resourcing and update tracking systems; interface with project teams
  • Collaborate with Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team
  • Develop, mentor, manage and coach CRA staff; perform accompanied site visits to assess CRA skills and developmental needs
  • Identify quality risks and recommend corrective action plans
  • Ensure staff have proper resources, training, materials, and access to systems
  • Ensure CRAs provide timely and accurate updates of all required administrative material on company systems
  • Work with Clinical Operations Management Team to improve CRA expectations and procedures
  • Develop and maintain metrics pertinent to CRA resource oversight; participate in interview process and conduct on-boarding training
  • Represent Precision for Medicine professionally; manage CRA staff according to company values and policies
  • Assist with planning, assigning, and directing of work and gather performance feedback
  • Perform other duties as assigned by Leadership

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 Precision for Medicine SOPs
  • High capacity for Emotional Intelligence and a passion for people management and development
  • Ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs
  • Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level
  • Demonstrates understanding and ability to work with EMRs and EDCs
  • Exhibits high self-motivation and is able to work and plan independently as well as in a team environment
  • Communicates both verbally and in written form in an acceptable manner
  • Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
  • Possesses practical knowledge of IT tools and systems in use on project teams