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About the Role

As an Associate Site Manager (Clinical Research Associate), you will be part of the Global Clinical Operations (GCO) Canada team, responsible for study site management through all phases of clinical trials. You will be the primary point of contact for study sites, driving patient recruitment, monitoring study conduct according to GCP standards, and ensuring compliance with regulations and SOPs.

Responsibilities

• Serve as the primary point of contact for study sites and liaise with study teams.
• Actively identify and drive patient recruitment strategies at assigned sites.
• Monitor study/site activities according to GCP standards and J&J GCO SOPs, including source document verification, ISF review, and drug accountability.
• Provide site training during initiation and ongoing to ensure compliance with regulations, SOPs, and trial-specific procedures.
• Ensure resolution of site-specific issues and partner with site staff to meet study timelines.
• Collaborate with the local study operations team to resolve protocol and site-specific issues.
• Utilize and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (TMF).

Requirements

• Bachelor of Science or equivalent degree in Biological Sciences required.
• Minimum of 1 year experience in onsite and offsite (remote) monitoring.
• Pharmaceutical industry clinical research trial experience preferred.
• Analytical/risk-based monitoring experience is highly preferred.
• Knowledge of several therapeutic areas is an asset (preferably including oncology).
• In-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements.
• Ability to operate and use various systems and databases (e.g., CTMS, EDC, TMF, various dashboards/metrics, IWRS, safety reporting).
• Strong communication and influencing skills to effectively manage study sites remotely and face-to-face.
• Strong team member and self-starter with the ability to work independently.
• Ability to establish a home office.
• Fluent in English language.

Skills

• Analytical Reasoning
• Business Behavior
• Business English
• Clinical Data Management
• Clinical Trials
• Clinical Trials Operations
• Execution Focus
• Issue Escalation
• Laboratory Operations
• Process Improvements
• Process Oriented
• Project Support
• Regulatory Environment
• Research and Development
• Research Ethics
• Study Management
• Time Management

Location

• Toronto, Ontario, Canada

Work Type

• Field-based
• Remote
• Onsite

Experience Level

• Associate

Education Level

• Bachelor of Science or equivalent degree in Biological Sciences

Salary/Compensations

• $72,000 – $116,150 CAD

Benefits

• Eligible for a discretionary performance bonus.

About the Company

• At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
• Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
• Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Equal Opportunity

• As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.