Johnson & Johnson Careers

Local Trial Manager

Toronto, Canada; Canada
Clinical Trial Administration


Job Description

Requisition ID: 7163171215

Janssen Pharmaceutical, a company of Johnson & Johnson is hiring a Local Trial Manager.  The preferred location is Toronto, ON, with consideration for a remote location in Canada.

 

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in hematology, oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.

                 

Responsibilities:

  • Overall project management of the Canadian component of multicentre, international registration studies and/or Medical Affairs studies (Phases 1-4)
  • Provide leadership to the local study team (e.g. Regional Site Managers/Monitors, document specialists, admin support)
  • Accountable to Global study team for trial coordination and study deliverables
  • Leadership of local study team. Contributions to local feasibility and investigator selection. Responsible for study start-up activities, subject recruitment and contingency plans at the country level, safety reporting, timely acquisition of quality data and trial documentation; study spend and forecast management
  • Ensure complete Trial Master File (essential trial documents) to parallel the progress of the clinical trial.
  • Audit and inspection readiness
  • Contribute to the development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement.
  • This position may require up to 10% domestic and international travel. 


Qualifications

  • BSc, RN or MSc or equivalent degree in Biological Sciences
  • Minimum of three years in Clinical Research including site management experience in clinical trials (phases 2 and 3 at minimum).
  • Experience with overall trial management and risk based trial management is an asset.   
  • In-depth knowledge of ICH-GCP and Canadian regulations
  • Strong project management skills with focus on study deliverables, trial/site oversight, quality and timelines
  • Knowledge of several therapeutic areas is an asset
  • Demonstrated skills in leadership and in the areas of judgement, communication, attention to detail, proactive problem-solving, analysis, negotiation, and innovation.
  • Strong prioritization, decision-making and adaptability skills. Ability to manage complexity and meet deadlines. Strategic, flexible and able to work well in a changing environment
  • Experience and high proficiency with electronic filing, data systems and reporting

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies.  Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success.  We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.


Primary Location
Canada-Ontario-Toronto
Other Locations
North America-Canada
Organization
Janssen Inc. (7710)
Job Function
Clinical Trial Administration
Requisition ID
7163171215