Janssen Inc, a company of Johnson & Johnson is hiring a Senior Site Manager. This position is a field based role covering the Greater Toronto Area and surroundings.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Driven by our commitment 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 Site Manager, 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 of 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 • Minimum of a Bachelor of Science, R.N., or equivalent degree, preferably in Biological Sciences. • Minimum of 3 years’ experience in on-site and remote monitoring pharmaceutical industry clinical research trials • Analytical/risk-based monitoring experience is highly preferred • Knowledge of several therapeutic areas is an asset (ideally 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, 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. • You may need to travel up to 50% (up to 2-3 days per week) with overnight stays (up to 1-2 nights on average).
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 have the opportunity to achieve their potential.
Primary Location Canada-Ontario-Toronto- Organization Janssen Inc. (7710) Job Function Clinical Trial Administration Requisition ID 5808190529