Job Description

Janssen Inc., a member of Johnson & Johnson\'s Family of Companies, is recruiting for a Senior Site Manager, located in the Greater Toronto Area. This position is a field-based role covering primarily Ontario with occasional travel outside of this province as needed.

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.

The Senior Site Manager (Senior Clinical Research Associate) will be part of our Global Clinical Operations (GCO) Canada group within Research & Development and will be responsible for study site management through the assessment/selection, initiation, maintenance and closure phases of a clinical trial (Phase 1-4 trials).

Principal Responsibilities:

• Primary point of contact for the study site; liaison with study teams.
• Actively identify and drive patient recruitment strategies at assigned sites.
• Monitor the study/site according to Good Clinical Practices (GCP) standards and our Janssen GCO Standard Operating Procedures (SOPs), both on-site and with remote contacts. This includes source document verification, Investigator Site File (ISF) review and accurate drug accountability.
• Provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial-specific tools and systems, and specialized procedures.
• Ensure resolution of site-specific issues and will partner closely with investigator and site staff to meet all our study timelines.
• Work closely with the local study operations team to resolve protocol and site-specific issues.
• Use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (eTMF) as required.

• A minimum of a Bachelor\'s degree, Nursing degree (RN) or equivalent is required. A degree in Biological Sciences is preferred.
• A minimum of 3 years of experience monitoring pharmaceutical industry clinical trials is required.
• Experience with analytical/risk-based monitoring is preferred.
• Experience in the Oncology Therapeutic Area (Hematology, Prostate Cancer, Lung Cancer, etc.) is preferred.
• In-depth knowledge of Good Clinical Practices (GCPs), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and local regulatory requirements is required.
• 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 strong communication and influencing skills to effectively manage study sites both remotely and face-to-face.
• Must be a strong team member and self-starter with the ability to work independently.
• The ability to actively drive patient recruitment strategies at assigned sites is required.
• The ability to partner closely with investigator and site staff to meet all study timelines is required.
• Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), 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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