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Senior Site Manager (Sr Clinical Research Associate) - Ontario
Requisition ID: 1288180511
Janssen Pharmaceutical, a company of Johnson & Johnson is hiring a Senior Site Manager. This position is a field based role covering mainly Ontario; occasional travel outside of the province as needed. The preferred location is the Toronto area.
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.
The Senior Site Manager will be part of the Global Clinical Operations (GCO) Canada group and will be responsible for site management through the assessment/selection, initiation, maintenance and closure phases of a clinical trial (Phase 1 – 4).
- Primary contact for the site; liaison with study teams.
- Proactively drive subject recruitment.
- Monitor according to GCP standards and GCO SOPs (to include source document verification, Trial Centre File review and accurate drug accountability).
- Responsible for resolution of site-specific issues and partnering with site to meet study milestones.
- Work with in-house team to resolve protocol-specific issues.
- Site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial–specific tools and systems, and specialized procedures.
- Maintain clinical trial tracking system (CTMS); update electronic Trial Master File (eTMF) as required.
- A minimum of a B.Sc., R.N., or equivalent degree is required, preferably in Biological Sciences.
- A minimum of 3 years’ experience monitoring pharmaceutical industry clinical trials is required.
- Knowledge of several therapeutic areas is an asset, oncology preferred.
- Bilingualism (English & French) is an asset.
- Ability to operate and proactively use various systems and databases (e.g. CTMS, eDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
- Analytical risk-based monitoring experience highly desirable.
- Environment to establish a home office.
- Willingness to travel up to 50% (up to 2-3 days per week) with overnight stays (up to 1-2 nights on average), is required.
- Strong communication and influencing skills to effectively manage study sites both remotely and face to face. Team player, self-starter with ability to work independently
- In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
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.
Janssen Inc. (7710)
Clinical Trial Administration