Senior Site Manager; Clinical Research Associate

Senior Site Manager (Clinical Research Associate)

Join to apply for the Senior Site Manager (Clinical Research Associate) role at Johnson & Johnson Innovative Medicine
.

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 Med Tech, 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.

• Job Function
  : R&D Operations
• Job Sub Function
  :
  Clinical Trial Support
• Job Category
  :
  Professional
• Location
  :
  Toronto, Ontario, Canada

We are searching for the best talent for a Senior Site Manager (Clinical Research Associate). This is a field‑based role covering primarily Ontario; occasional travel outside of this province may be required. Ideally, the Senior Site Manager should be located in the Greater Toronto Area. As a member of the Global Clinical Operations (GCO) Canada group within Research & Development, you will be responsible for study site management through the assessment, selection, initiation, maintenance, and closure phases of a clinical trial (Phase 1‑4).

• Primary point of contact for the study site, acting as a liaison with study teams.
• Actively identify and drive patient recruitment strategies at assigned sites.
• Monitor the study/site according to GCP standards and Janssen GCO SOPs, on‑site and remotely, including source document verification, Investigator Site File 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.
• Resolve site‑specific issues and partner closely with investigators and site staff to meet all study timelines.
• Collaborate 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.

• Bachelor of Science, R.N., or equivalent degree in Biological Sciences preferred.
• Minimum 3 years of onsite and offsite monitoring experience, preferably in the pharmaceutical industry.
• Analytical/risk‑based monitoring experience highly preferred.
• Knowledge of several therapeutic areas; experience in Oncology and Early Development highly preferred.
• In‑depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements.
• Ability to use various systems and databases (CTMS, EDC, eTMF, dashboards/metrics, IWRS, safety reporting).
• Strong communication and influencing skills to 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.
• Travel: 30–50%. Onsite monitoring visits will be conducted in combination with offsite (remote) visits, mainly within the region with occasional travel to neighboring provinces.

• Business Behavior, Business English, Clinical Data Management, Clinical Trials Operations, Execution Focus, Laboratory Operations, Mentorship, Proactive Behavior, Problem Solving, Process Improvements, Project Support, Regulatory Environment, Regulatory Inspections, Research and Development, Research Ethics, Study Management, Time Management.