Clinical Project Manager / Local Trial Manager - Medical Affairs

Job description

Janssen Pharmaceutical Companies of Johnson & Johnson, is currently hiring for a Clinical Project Manager / Local Trial Manager to support our Medical Affairs team. 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.

Responsibilities:

· Overall project management of local Medical Affairs studies or the Canadian component of multicentre, international Medical Affairs studies (Phases 3b/4 interventional and non-interventional studies)
· Strategic partnering with Medical Affairs, global study teams and key investigators
· Accountable to Local Medical Affairs partners and/or global study teams 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.
· These positions may require up to 5% domestic and international travel.

Desired profile

Qualifications :

·  A minimum of a Bachelor's degree or RN in Biological Sciences is required.
·  Minimum of three years in Clinical Research including in-house trial management and project management experience with Phase 1-4 trials
·  Knowledge of several therapeutic areas is required; experience in the strategic management and implementation of local phase 3b/4 and non-interventional trials is an 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 and data systems
·  Strong attention to detail and focus on quality results
·  Proven interdependent and strategic partnering ability
·  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.