J&J Family of Companies Clinical Project Manager/Local Trial Manager (2 openings) in Toronto, Ontario

Janssen Pharmaceutical, a company of Johnson & Johnson is hiring a Clinical Project Manager/Local Trial Manager (2 openings). The preferred location is Toronto, ON, with consideration for a remote location in Canada.

  • 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 5% domestic and international travel.

Qualifications

  • A minimum of a Bachelor’s degree or RN in Biological Sciences is required.

  • A minimum of three years in Clinical Research including trial management and project management experience in clinical trials (phases 2 and 3 preferred). Experience with 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 oversight, quality and timelines.

  • Knowledge of several therapeutic areas is required.

  • Demonstrated skills in leadership and in the areas of judgement, attention to detail, problem-solving, analysis, negotiation, and innovation.

  • Strong prioritization, decision-making and adaptability skills. Ability to manage complexity. Flexible and able to work well in a changing environment.

  • Collaboration and conflict resolution skills.

  • 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

2310170612