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Job Function:
R&D OperationsJob Sub Function:
Clinical Trial SupportJob Category:
ProfessionalAll Job Posting Locations:
Toronto, Ontario, CanadaJob Description:
About Innovative Medicine
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.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Senior Site Manager (Clinical Research Associate). This position is a field-based role covering primarily Ontario; occasional travel outside of this province as needed. Ideally, the Senior Site Manager should be located in the Greater Toronto Area.
As a Senior Site Manager (Senior Clinical Research Associate), you 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).
- You are the primary point of contact for the study site, liaison with study teams.
- Your responsibilities include actively identifying and driving patient recruitment strategies at assigned sites.
- You are responsible for monitoring the study/site according to GCP standards and our Janssen GCO SOPs, both on-site and with remote contacts. This includes source document verification, Investigator Site File (ISF) review and accurate drug accountability.
- You will provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial-specific tools and systems, and specialized procedures.
- You will ensure resolution of site-specific issues and will partner closely with investigator and site staff to meet all our study timelines.
- You will work closely with the local study operations team to resolve protocol and site-specific issues.
- You will use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (eTMF) as required.
Qualifications
- Bachelor of Science, R.N., or equivalent degree in Biological Sciences preferred
- Minimum 3 years of experience in onsite and offsite (remote) monitoring, preferably in the pharmaceutical industry
- Analytical/risk-based monitoring experience is highly preferred
- Knowledge of several therapeutic areas; experience in Oncology, Early Development is highly preferred.
- 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, eTMF, various dashboards/metrics, IWRS, safety reporting)
- Strong communication and influencing skills to effectively manage study sites both 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) monitoring visits. You will be assigned sites mainly within your region/province, with occasional need for travel to neighboring provinces
Required Skills:
Preferred Skills:
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 ManagementTop Skills
Johnson & Johnson Guelph, Ontario, CAN Office
890 Woodlawn Rd W, Guelph, Ontario, Canada, N1K 1A5
