Job Description

Janssen Inc., a member of Johnson & Johnson\'s Family of Companies, is recruiting for a Senior Local Trial Manager. This position can be located remotely within Canada.

At Janssen, we are dedicated to addressing and solving some of the most meaningful unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and metabolic and chronic diseases. Passionate about our dedication 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.

As a Senior Local Trial Manager, you will be part of our Global Clinical Operations (GCO) Canada group within Research & Development and will be responsible for project management through the assessment/selection, initiation, maintenance and closure phases of clinical trials (Phase 1 - 4 trials).

Principal Responsibilities:

• Overall project management of the Canadian component of multi-center , 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).
• Accountability to Global study team for trial coordination and meeting study milestones.
• Support local feasibility and investigator selection. Leading study start-up activities, subject recruitment and retention planning at the country level, timely acquisition of quality data and trial documentation; handling Canadian study payments, spend and forecast management.
• Ensure Trial Master File (essential trial documents) is complete and up to date to support audit and inspection readiness.
• Participation in the development and improvement of departmental procedures and processes in the scope of the company\'s effort towards continuous quality improvement.

• A minimum of a Bachelor\'s degree, Nursing degree (RN) or equivalent is required. A degree in Biological Sciences is preferred.
• A minimum of 5 years of experience in clinical research, including trial management of clinical trials (Phases 2 and 3 at minimum) is required.
• Experience in the Pharmaceutical industry is preferred.
• Prior experience as a Local Trial Manager/Project Manager is required.
• In-depth knowledge of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH-GCP) and Canadian regulations is required.
• Strong project management skills, with focus on study deliverables , trial/site oversight, quality and timelines, required.
• Experience with risk-based trial management is preferred.
• Experience in the Oncology therapeutic area is preferred.
• Knowledge of several therapeutic areas is preferred.
• Phase 1 treatment/patient trial experience is preferred.
• Strong computer skills in appropriate software applications and related clinical systems (e.g., CTMS, eDC, eTMF, various dashboards/metrics, IWRS, safety reporting) is required.
• Must have excellent oral and written communication skills, including strong presentation skills.
• Must have proven skills in leadership and in the areas of judgement, risk assessment and mitigation, attention to detail, problem-solving, analysis, decision-making, conflict resolution and innovation.
• Must be a strong team member and self-starter with the ability to work independently.
• Must have the ability to establish a home office.
• The ability to handle complexity and be flexible to work well in a changing environment is required.
• The ability to collaborate with various internal and external partners and influence decision-making is required.
• Minimal domestic and international travel, based on the needs of the business, is required .

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 can achieve their potential.

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