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Clinical Project Manager/Local Trial Manager
Requisition ID: 7739180330
Janssen Pharmaceutical Companies of Johnson & Johnson, is currently hiring for a Clinical Project Manager / 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 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.com/canada for more information.
- Overall project management of the Canadian component of multicentre, international registration studies and/or Medical Affairs studies (Phases 1-4)
- Accountable to Global study teams for trial coordination and study deliverables for trial coordination and study deliverables
- Provide leadership to the local study team (e.g. Regional Site Managers/Monitors, document specialists, admin support)
- Responsible for local feasibility and investigator selection, 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 preparation
- 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.
- A minimum of a Bachelor’s degree or RN in Biological Sciences is required.
- Minimum of three years in Clinical Research including trial management and project management experience in clinical trials (phases 2 and 3 at minimum).
- Experience with risk based trial management is an asset.
- Knowledge of several therapeutic areas is as asset
- In-depth knowledge of ICH-GCP and Canadian regulations
- Strong project management skills with focus on study deliverables, oversight, quality and timelines
- Ability to manage complexity; flexible and able to work well in a changing environment
- Excellent oral and written communication skills including strong presentation skills. French (written and oral) is an asset
- Experience and high proficiency with electronic filing, data systems and reporting
- Strong attention to detail and focus on quality results
- Proven interdependent and strategic partnering ability
- Collaboration and conflict resolution skills.
- Solid skills in the areas of judgement, problem-solving, leadership, analysis, negotiation, and innovation
- Ability to work independently
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