Assoc Dir, Clinical Research Assoc Team

Category:  Clinical Development and Medical
Location: 

Mississauga, Ontario, CA

   

Associate Director, Clinical Research Associate Team

                                                               

 

Purpose of the Job

  • Provides tactical leadership to staff, within the Field Management (FM) function of North America Clinical Operations (NACO)
  • Takes ownership to position and deliver upon near and mid-term NACO goals, including those specifically aligned with the planning and successful delivery of studies within the clinical trial portfolio
  • Leads and delivers upon improvement/innovation projects for NACO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations
  • Provides leadership in continually changing environment, supporting a future focused approach, leveraging competencies, tools, and technology, and with change management skills
  • Ensures business needs are met through alignment of business plans and operational need, and through efficiencies and optimization of resource allocation

 

 

Key Areas of Responsibility:

  • Responsible for quality and performance related to managing clinical trial resources; managing and developing CRAs in regions; and developing and maintaining relationships with clinical trial Investigators, Site Staff and Clinical Research Organizations.
  • Drives the objective, settingprioritization and tracking within the region; provides relevant input and guidance to other areas within NACO
  • Implements the clinical development strategy
  • Ensures alignment and support is in place to plan and deliver all relevant services/tasks in support of the planning and quality delivery of clinical trials, including assessment and allocation of resources for CRAs (including contracted staff) and the operational aspects of planning and managing site performance, documentation strategies, protocols, and processes
  • Provides input to relevant budgets
  • Trains, develops and engages staff as required, by assuring training plans and material are developed and deployed within department and across NACO
  • Demonstrates technical expertise within responsibility areas, staying up to date with new practices and building knowledge of emerging trends and advances within area  

 

 

Key Compliance:

  • Manages Regional Monitors driving timelines and deliverables in order to achieve key milestones in compliance with ICH-GCP, Canadian regulatory requirements, Novo Nordisk SOPs, and Clinical Development Guidelines.
  • Completes training in ISOTrain by effective date and identifies potential challenges adhering to global SOPS for Clinical Development and escalates to Director, Field Management.

 

Education (Minimum Requirements):

  • Bachelor’s Degree is required (University graduate (BSc), Nursing Degree/Diploma)

 

Experience (Minimum Requirements):

  • A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required of which 4 years must be directly related to clinical trial execution.
  • A minimum of 3 years’ experience in peer-to-peer coaching/mentoring is required.
  • Analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from representation at a management level.
  • Expert in ICH-GCP principles and the application of those principles to trial design, planning and conduct of clinical trials
  • In-depth knowledge and direct experience/interactions with the Health Canada (or equivalent regulatory authority) in relation to the design, planning and conduct of GCP clinical trials
  • Excellent communications skills (verbal, written, presentation) in English
  • Demonstrated collaborative and stakeholder management skills
  • Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management
  • Demonstrated computer skills (Word, Excel, PowerPoint, Outlook)

 

 

Working Conditions:

  • Works from home office
  • Overnight (local) stays may be required – 20%
  • May on occasion be required to work and/or travel on weekends and/or company holidays
  • Works at hospitals, doctors’ offices – reviews patient charts/medical records

 

 

Internal Application Deadline:  September 12, 2022

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.