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.
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.
Janssen Inc. (7710)
Clinical Trial Administration